Trial Outcomes & Findings for Working Memory Training Combined With Transcranial Magnetic Stimulation in Smokers (NCT NCT03337113)
NCT ID: NCT03337113
Last Updated: 2022-05-02
Results Overview
The Delay to Smoking Analogue Task is a behavioral choice paradigm that is sensitive to smoking medication effects in which participants earn monetary rewards for delaying initiation of cigarette smoking in 5-minute increments over a 50-minute period, following 3-hours of observed smoking deprivation. Range = 0 - 50 minutes. Higher scores indicate better ability to delay smoking.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
an average of 30 days after baseline
Results posted on
2022-05-02
Participant Flow
Participant milestones
| Measure |
WMT + rTMS
WMT + rTMS is the Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. Both conditions are active.
Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis.
repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard "F3" location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application.
|
Sham WMT + rTMS
Sham WMT + rTMS is the sham Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of rTMS. WMT is inactive.
Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.
repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard "F3" location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application.
|
WMT + Sham rTMS
WMT + sham rTMS is the Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of WMT. rTMS is inactive.
Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis. An identical protocol and software have demonstrated efficacy in increasing WM capacity, and this improvement in WM predicts reduction in addictive behavior.
Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation.
|
Sham WMT + Sham rTMS
sham WMT + sham rTMS is the sham Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. Both are inactive in this arm.
Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.
Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
12
|
13
|
|
Overall Study
COMPLETED
|
12
|
9
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
1
|
2
|
Reasons for withdrawal
| Measure |
WMT + rTMS
WMT + rTMS is the Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. Both conditions are active.
Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis.
repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard "F3" location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application.
|
Sham WMT + rTMS
Sham WMT + rTMS is the sham Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of rTMS. WMT is inactive.
Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.
repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard "F3" location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application.
|
WMT + Sham rTMS
WMT + sham rTMS is the Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of WMT. rTMS is inactive.
Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis. An identical protocol and software have demonstrated efficacy in increasing WM capacity, and this improvement in WM predicts reduction in addictive behavior.
Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation.
|
Sham WMT + Sham rTMS
sham WMT + sham rTMS is the sham Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. Both are inactive in this arm.
Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.
Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
2
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Working Memory Training Combined With Transcranial Magnetic Stimulation in Smokers
Baseline characteristics by cohort
| Measure |
WMT + rTMS
n=12 Participants
WMT + rTMS is the Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. Both conditions are active.
Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis.
repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard "F3" location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application.
|
Sham WMT + rTMS
n=9 Participants
Sham WMT + rTMS is the sham Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of rTMS. WMT is inactive.
Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.
repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard "F3" location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application.
|
WMT + Sham rTMS
n=11 Participants
WMT + sham rTMS is the Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of WMT. rTMS is inactive.
Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis. An identical protocol and software have demonstrated efficacy in increasing WM capacity, and this improvement in WM predicts reduction in addictive behavior.
Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation.
|
Sham WMT + Sham rTMS
n=11 Participants
sham WMT + sham rTMS is the sham Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. Both are inactive in this arm.
Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.
Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 10.45 • n=5 Participants
|
44.77 years
STANDARD_DEVIATION 8.05 • n=7 Participants
|
45.72 years
STANDARD_DEVIATION 9.23 • n=5 Participants
|
40.36 years
STANDARD_DEVIATION 9.88 • n=4 Participants
|
43.25 years
STANDARD_DEVIATION 9.43 • n=21 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Gender · Does not Identify as Male or Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · Non-Hispanic White
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · Non-Hispanic Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · Non-Hispanic Multiracial
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · Hispanic White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Education (12 years or less)
12 years or less
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Education (12 years or less)
more than 12 years
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Employment
Not working
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Employment
working at least part time
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Cigarettes per day
|
17.16 cigarettes per day
STANDARD_DEVIATION 7.48 • n=5 Participants
|
18.33 cigarettes per day
STANDARD_DEVIATION 7.93 • n=7 Participants
|
22.27 cigarettes per day
STANDARD_DEVIATION 8.02 • n=5 Participants
|
17.54 cigarettes per day
STANDARD_DEVIATION 5.41 • n=4 Participants
|
18.81 cigarettes per day
STANDARD_DEVIATION 7.30 • n=21 Participants
|
|
Fagerstrom Test for Cigarette Dependence (FTCD)
|
6.58 units on a scale
STANDARD_DEVIATION 1.88 • n=5 Participants
|
6.56 units on a scale
STANDARD_DEVIATION 1.66 • n=7 Participants
|
6.27 units on a scale
STANDARD_DEVIATION 1.00 • n=5 Participants
|
6.00 units on a scale
STANDARD_DEVIATION 2.00 • n=4 Participants
|
6.35 units on a scale
STANDARD_DEVIATION 1.64 • n=21 Participants
|
|
General Cigarette Craving (past 24 hrs)
|
1.83 units on a scale
STANDARD_DEVIATION 1.03 • n=5 Participants
|
1.67 units on a scale
STANDARD_DEVIATION 1.00 • n=7 Participants
|
1.82 units on a scale
STANDARD_DEVIATION .75 • n=5 Participants
|
1.45 units on a scale
STANDARD_DEVIATION .82 • n=4 Participants
|
1.70 units on a scale
STANDARD_DEVIATION .88 • n=21 Participants
|
|
Age started smoking (years)
|
14.25 years
STANDARD_DEVIATION 2.09 • n=5 Participants
|
14.11 years
STANDARD_DEVIATION 3.14 • n=7 Participants
|
12.63 years
STANDARD_DEVIATION 4.31 • n=5 Participants
|
14.36 years
STANDARD_DEVIATION 2.41 • n=4 Participants
|
13.83 years
STANDARD_DEVIATION 3.06 • n=21 Participants
|
PRIMARY outcome
Timeframe: an average of 30 days after baselineThe Delay to Smoking Analogue Task is a behavioral choice paradigm that is sensitive to smoking medication effects in which participants earn monetary rewards for delaying initiation of cigarette smoking in 5-minute increments over a 50-minute period, following 3-hours of observed smoking deprivation. Range = 0 - 50 minutes. Higher scores indicate better ability to delay smoking.
Outcome measures
| Measure |
WMT + rTMS
n=9 Participants
WMT + rTMS is the Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. Both conditions are active.
Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis.
repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard "F3" location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application.
|
Sham WMT + rTMS
n=7 Participants
Sham WMT + rTMS is the sham Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of rTMS. WMT is inactive.
Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.
repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard "F3" location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application.
|
WMT + Sham rTMS
n=11 Participants
WMT + sham rTMS is the Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of WMT. rTMS is inactive.
Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis. An identical protocol and software have demonstrated efficacy in increasing WM capacity, and this improvement in WM predicts reduction in addictive behavior.
Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation.
|
Sham WMT + Sham rTMS
n=8 Participants
sham WMT + sham rTMS is the sham Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. Both are inactive in this arm.
Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.
Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation.
|
|---|---|---|---|---|
|
Time to Lapse on a Smoking Lapse Analogue Task
|
16.11 minutes
Standard Deviation 24.21
|
38.0 minutes
Standard Deviation 18.65
|
26.36 minutes
Standard Deviation 25.40
|
15.25 minutes
Standard Deviation 18.49
|
PRIMARY outcome
Timeframe: Change from baseline score to score at 30 daysNIH Examiner N-back score. The minimum value is 0 and maximum is 90, higher scores indicate a better outcome. Calculated change scores are presented (outcome score at day 30 minus baseline score).
Outcome measures
| Measure |
WMT + rTMS
n=12 Participants
WMT + rTMS is the Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. Both conditions are active.
Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis.
repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard "F3" location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application.
|
Sham WMT + rTMS
n=9 Participants
Sham WMT + rTMS is the sham Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of rTMS. WMT is inactive.
Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.
repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard "F3" location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application.
|
WMT + Sham rTMS
n=11 Participants
WMT + sham rTMS is the Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of WMT. rTMS is inactive.
Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis. An identical protocol and software have demonstrated efficacy in increasing WM capacity, and this improvement in WM predicts reduction in addictive behavior.
Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation.
|
Sham WMT + Sham rTMS
n=10 Participants
sham WMT + sham rTMS is the sham Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. Both are inactive in this arm.
Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.
Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation.
|
|---|---|---|---|---|
|
Working Memory Performance 1
|
7.08 units on a scale
Standard Deviation 6.58
|
4.11 units on a scale
Standard Deviation 7.08
|
3.73 units on a scale
Standard Deviation 4.96
|
4.67 units on a scale
Standard Deviation 7.01
|
PRIMARY outcome
Timeframe: Change from baseline score to score at 30 daysNIH Examiner Dot Counting Task score. The minimum total score is 0 and the maximum score is 27, higher scores indicate a better outcome. Calculated change scores are presented (outcome score at day 30 minus baseline score).
Outcome measures
| Measure |
WMT + rTMS
n=12 Participants
WMT + rTMS is the Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. Both conditions are active.
Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis.
repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard "F3" location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application.
|
Sham WMT + rTMS
n=9 Participants
Sham WMT + rTMS is the sham Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of rTMS. WMT is inactive.
Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.
repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard "F3" location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application.
|
WMT + Sham rTMS
n=11 Participants
WMT + sham rTMS is the Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of WMT. rTMS is inactive.
Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis. An identical protocol and software have demonstrated efficacy in increasing WM capacity, and this improvement in WM predicts reduction in addictive behavior.
Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation.
|
Sham WMT + Sham rTMS
n=10 Participants
sham WMT + sham rTMS is the sham Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. Both are inactive in this arm.
Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.
Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation.
|
|---|---|---|---|---|
|
Working Memory Performance 2
|
1.75 units on a scale
Standard Deviation 1.96
|
1.44 units on a scale
Standard Deviation 7.16
|
0.73 units on a scale
Standard Deviation 5.48
|
0.80 units on a scale
Standard Deviation 3.94
|
PRIMARY outcome
Timeframe: Change from baseline score to score at 30 daysMean End Level Score on Maastricht University Working Memory Tasks. For each scale (i.e. visuospatial, back-digit, and letter-sequencing) the minimum total is 3 and the maximum is 15, higher scores indicate a better outcome.
Outcome measures
| Measure |
WMT + rTMS
n=12 Participants
WMT + rTMS is the Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. Both conditions are active.
Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis.
repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard "F3" location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application.
|
Sham WMT + rTMS
n=8 Participants
Sham WMT + rTMS is the sham Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of rTMS. WMT is inactive.
Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.
repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard "F3" location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application.
|
WMT + Sham rTMS
n=11 Participants
WMT + sham rTMS is the Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of WMT. rTMS is inactive.
Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis. An identical protocol and software have demonstrated efficacy in increasing WM capacity, and this improvement in WM predicts reduction in addictive behavior.
Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation.
|
Sham WMT + Sham rTMS
n=11 Participants
sham WMT + sham rTMS is the sham Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. Both are inactive in this arm.
Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.
Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation.
|
|---|---|---|---|---|
|
Working Memory Performance 3
Maastricht Visuospatial
|
1.33 units on a scale
Standard Deviation .776
|
1.00 units on a scale
Standard Deviation 1.60
|
1.00 units on a scale
Standard Deviation 1.18
|
.636 units on a scale
Standard Deviation 1.29
|
|
Working Memory Performance 3
Maastricht Back digit
|
1.00 units on a scale
Standard Deviation 2.52
|
1.62 units on a scale
Standard Deviation 1.41
|
3.73 units on a scale
Standard Deviation 2.69
|
.910 units on a scale
Standard Deviation 2.70
|
|
Working Memory Performance 3
Maastricht Letter-Sequencing
|
3.25 units on a scale
Standard Deviation 2.26
|
2.38 units on a scale
Standard Deviation 3.38
|
2.0 units on a scale
Standard Deviation 3.0
|
1.82 units on a scale
Standard Deviation 2.32
|
PRIMARY outcome
Timeframe: throughout 60 day study participation, cigarettes per day assessed at outcome reportedSelf reported number of cigarettes smoked daily
Outcome measures
| Measure |
WMT + rTMS
n=12 Participants
WMT + rTMS is the Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. Both conditions are active.
Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis.
repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard "F3" location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application.
|
Sham WMT + rTMS
n=9 Participants
Sham WMT + rTMS is the sham Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of rTMS. WMT is inactive.
Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.
repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard "F3" location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application.
|
WMT + Sham rTMS
n=11 Participants
WMT + sham rTMS is the Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of WMT. rTMS is inactive.
Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis. An identical protocol and software have demonstrated efficacy in increasing WM capacity, and this improvement in WM predicts reduction in addictive behavior.
Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation.
|
Sham WMT + Sham rTMS
n=11 Participants
sham WMT + sham rTMS is the sham Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. Both are inactive in this arm.
Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.
Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation.
|
|---|---|---|---|---|
|
Cigarette Consumption
|
16.00 cigarettes per day
Standard Deviation 10.82
|
15.33 cigarettes per day
Standard Deviation 9.0
|
17.36 cigarettes per day
Standard Deviation 9.89
|
15.72 cigarettes per day
Standard Deviation 11.28
|
SECONDARY outcome
Timeframe: Change from baseline score to score at 30 daysDiscounting Rate on the Monetary Choice Questionnaire, assessed by k (log transformed). Individuals made hypothetical choices between smaller immediate rewards (e.g. $11 today) and larger delayed rewards (e.g. $30 in 7 days) at varying levels of hyperbolic-like discounting. Overall temporal discounting function (k) was assessed; larger values indicate steeper discounting which reflects a worse outcome. Total score range = 0 - 0.25.
Outcome measures
| Measure |
WMT + rTMS
n=12 Participants
WMT + rTMS is the Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. Both conditions are active.
Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis.
repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard "F3" location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application.
|
Sham WMT + rTMS
n=9 Participants
Sham WMT + rTMS is the sham Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of rTMS. WMT is inactive.
Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.
repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard "F3" location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application.
|
WMT + Sham rTMS
n=11 Participants
WMT + sham rTMS is the Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of WMT. rTMS is inactive.
Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis. An identical protocol and software have demonstrated efficacy in increasing WM capacity, and this improvement in WM predicts reduction in addictive behavior.
Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation.
|
Sham WMT + Sham rTMS
n=11 Participants
sham WMT + sham rTMS is the sham Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. Both are inactive in this arm.
Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.
Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation.
|
|---|---|---|---|---|
|
Delay Discounting
|
.131 units on a scale
Standard Deviation .377
|
.202 units on a scale
Standard Deviation .316
|
-.178 units on a scale
Standard Deviation 3.06
|
-.053 units on a scale
Standard Deviation .552
|
SECONDARY outcome
Timeframe: Change from baseline score to score at 30 daysDemand characteristics on the Cigarette Purchase Task. Demand sensitivity indicates sensitivity to change in price, with higher values reflecting higher sensitivity to the monetary reinforcer rather than the substance, thus higher scores reflect a better outcome. Score range = 0 - .100.
Outcome measures
| Measure |
WMT + rTMS
n=11 Participants
WMT + rTMS is the Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. Both conditions are active.
Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis.
repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard "F3" location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application.
|
Sham WMT + rTMS
n=9 Participants
Sham WMT + rTMS is the sham Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of rTMS. WMT is inactive.
Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.
repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard "F3" location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application.
|
WMT + Sham rTMS
n=10 Participants
WMT + sham rTMS is the Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of WMT. rTMS is inactive.
Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis. An identical protocol and software have demonstrated efficacy in increasing WM capacity, and this improvement in WM predicts reduction in addictive behavior.
Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation.
|
Sham WMT + Sham rTMS
n=11 Participants
sham WMT + sham rTMS is the sham Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. Both are inactive in this arm.
Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.
Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation.
|
|---|---|---|---|---|
|
Cigarette Demand
|
-.113 units on a scale
Standard Deviation .426
|
.091 units on a scale
Standard Deviation .133
|
.208 units on a scale
Standard Deviation .256
|
.197 units on a scale
Standard Deviation .376
|
Adverse Events
WMT + rTMS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham WMT + rTMS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
WMT + Sham rTMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham WMT + Sham rTMS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
WMT + rTMS
n=12 participants at risk
WMT + rTMS is the Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. Both conditions are active.
Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis.
repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard "F3" location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application.
|
Sham WMT + rTMS
n=9 participants at risk
Sham WMT + rTMS is the sham Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of rTMS. WMT is inactive.
Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.
repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard "F3" location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application.
|
WMT + Sham rTMS
n=11 participants at risk
WMT + sham rTMS is the Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of WMT. rTMS is inactive.
Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis. An identical protocol and software have demonstrated efficacy in increasing WM capacity, and this improvement in WM predicts reduction in addictive behavior.
Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation.
|
Sham WMT + Sham rTMS
n=11 participants at risk
sham WMT + sham rTMS is the sham Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. Both are inactive in this arm.
Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.
Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation.
|
|---|---|---|---|---|
|
General disorders
Discomfort during stimulation session.
|
8.3%
1/12 • Number of events 1 • The time frame was approximately 4 weeks, from the baseline study visit, throughout the treatment application period, until the final outcome assessment.
Definitions do not differ from clinicaltrials.gov definitions.
|
11.1%
1/9 • Number of events 1 • The time frame was approximately 4 weeks, from the baseline study visit, throughout the treatment application period, until the final outcome assessment.
Definitions do not differ from clinicaltrials.gov definitions.
|
0.00%
0/11 • The time frame was approximately 4 weeks, from the baseline study visit, throughout the treatment application period, until the final outcome assessment.
Definitions do not differ from clinicaltrials.gov definitions.
|
9.1%
1/11 • Number of events 1 • The time frame was approximately 4 weeks, from the baseline study visit, throughout the treatment application period, until the final outcome assessment.
Definitions do not differ from clinicaltrials.gov definitions.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place