Trial Outcomes & Findings for Transcranial Magnetic Stimulation Used to Both Measure Cortical Excitability and Explore Methamphetamine Cue Craving (NCT NCT01685463)
NCT ID: NCT01685463
Last Updated: 2020-04-01
Results Overview
The subject is asked to rate craving with 0 mm being " no craving at all" and 100 mm representing "the most craving I have ever had".
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
Change from Baseline in Craving rating 10 minutes after TMS
Results posted on
2020-04-01
Participant Flow
Participant milestones
| Measure |
Transcranial Magnetic Stimulation
Transcranial magnetic stimulation (TMS) is a noninvasive brain stimulation technology that can focally stimulate the brain of an awake individual. The brain stimulation techniques could theoretically improve the efficacy of smoking cessation.
Transcranial Magnetic Stimulation: Active TMS:1 Hz, 100% motor threshold TMS for 15 minutes, total 900 pulses.
Electrical stimulation instead.
|
Sham Transcranial Magnetic Stimulation
Sham-TMS procedures: After rTMS determination, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes will be connected to an Epix VT Transcutaneous Electrical nerve stimulation device.
Sham Transcranial Magnetic Stimulation: The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS. The sham-TMS scalp discomfort will be matched to that of active TMS.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transcranial Magnetic Stimulation Used to Both Measure Cortical Excitability and Explore Methamphetamine Cue Craving
Baseline characteristics by cohort
| Measure |
Transcranial Magnetic Stimulation
n=10 Participants
Transcranial magnetic stimulation (TMS) is a noninvasive brain stimulation technology that can focally stimulate the brain of an awake individual. The brain stimulation techniques could theoretically improve the efficacy of smoking cessation.
Transcranial Magnetic Stimulation: Active TMS:1 Hz, 100% motor threshold TMS for 15 minutes, total 900 pulses.
Electrical stimulation instead.
|
Sham Transcranial Magnetic Stimulation
n=8 Participants
Sham-TMS procedures: After rTMS determination, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes will be connected to an Epix VT Transcutaneous Electrical nerve stimulation device.
Sham Transcranial Magnetic Stimulation: The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS. The sham-TMS scalp discomfort will be matched to that of active TMS.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
34.7 years
STANDARD_DEVIATION 10.6 • n=93 Participants
|
32.5 years
STANDARD_DEVIATION 14.4 • n=4 Participants
|
33.7 years
STANDARD_DEVIATION 11.2 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline in Craving rating 10 minutes after TMSThe subject is asked to rate craving with 0 mm being " no craving at all" and 100 mm representing "the most craving I have ever had".
Outcome measures
| Measure |
Transcranial Magnetic Stimulation
n=10 Participants
Transcranial magnetic stimulation (TMS) is a noninvasive brain stimulation technology that can focally stimulate the brain of an awake individual. The brain stimulation techniques could theoretically improve the efficacy of smoking cessation.
Transcranial Magnetic Stimulation: Active TMS:1 Hz, 100% motor threshold TMS for 15 minutes, total 900 pulses.
Electrical stimulation instead.
|
Sham Transcranial Magnetic Stimulation
n=8 Participants
Sham-TMS procedures: After rTMS determination, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes will be connected to an Epix VT Transcutaneous Electrical nerve stimulation device.
Sham Transcranial Magnetic Stimulation: The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS. The sham-TMS scalp discomfort will be matched to that of active TMS.
|
|---|---|---|
|
Cue Craving Rating
|
9.36 scores on a scale
Standard Error 0.75
|
7.92 scores on a scale
Standard Error 0.85
|
SECONDARY outcome
Timeframe: Baseline to 10 minutes after TMSResting motor threshold (RMT); on a scale of 0-100 with 100 being most power given to enact a motor response
Outcome measures
| Measure |
Transcranial Magnetic Stimulation
n=10 Participants
Transcranial magnetic stimulation (TMS) is a noninvasive brain stimulation technology that can focally stimulate the brain of an awake individual. The brain stimulation techniques could theoretically improve the efficacy of smoking cessation.
Transcranial Magnetic Stimulation: Active TMS:1 Hz, 100% motor threshold TMS for 15 minutes, total 900 pulses.
Electrical stimulation instead.
|
Sham Transcranial Magnetic Stimulation
n=8 Participants
Sham-TMS procedures: After rTMS determination, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes will be connected to an Epix VT Transcutaneous Electrical nerve stimulation device.
Sham Transcranial Magnetic Stimulation: The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS. The sham-TMS scalp discomfort will be matched to that of active TMS.
|
|---|---|---|
|
Change in Baseline of Resting Motor Threshold
|
47.3 units on a scale
Standard Deviation 16.2
|
47.2 units on a scale
Standard Deviation 13.5
|
SECONDARY outcome
Timeframe: Baseline and 10 minutes after TMSCortical Silent Period is measured in seconds
Outcome measures
| Measure |
Transcranial Magnetic Stimulation
n=10 Participants
Transcranial magnetic stimulation (TMS) is a noninvasive brain stimulation technology that can focally stimulate the brain of an awake individual. The brain stimulation techniques could theoretically improve the efficacy of smoking cessation.
Transcranial Magnetic Stimulation: Active TMS:1 Hz, 100% motor threshold TMS for 15 minutes, total 900 pulses.
Electrical stimulation instead.
|
Sham Transcranial Magnetic Stimulation
n=8 Participants
Sham-TMS procedures: After rTMS determination, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes will be connected to an Epix VT Transcutaneous Electrical nerve stimulation device.
Sham Transcranial Magnetic Stimulation: The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS. The sham-TMS scalp discomfort will be matched to that of active TMS.
|
|---|---|---|
|
Change in Cortical Silent Period
|
0.163 seconds
Standard Deviation .053
|
.139 seconds
Standard Deviation .036
|
SECONDARY outcome
Timeframe: Baseline and 10 minutes after TMSRecruitment Curve (RC) Slope, measured at angle of slope
Outcome measures
| Measure |
Transcranial Magnetic Stimulation
n=10 Participants
Transcranial magnetic stimulation (TMS) is a noninvasive brain stimulation technology that can focally stimulate the brain of an awake individual. The brain stimulation techniques could theoretically improve the efficacy of smoking cessation.
Transcranial Magnetic Stimulation: Active TMS:1 Hz, 100% motor threshold TMS for 15 minutes, total 900 pulses.
Electrical stimulation instead.
|
Sham Transcranial Magnetic Stimulation
n=8 Participants
Sham-TMS procedures: After rTMS determination, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes will be connected to an Epix VT Transcutaneous Electrical nerve stimulation device.
Sham Transcranial Magnetic Stimulation: The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS. The sham-TMS scalp discomfort will be matched to that of active TMS.
|
|---|---|---|
|
Change Recruitment Curve (RC) Slope
|
.272 ratio
Standard Deviation .196
|
.135 ratio
Standard Deviation .073
|
Adverse Events
Transcranial Magnetic Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Transcranial Magnetic Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place