Trial Outcomes & Findings for TMS-fMRI for Neural Pathway in Smokers (NCT NCT02665338)
NCT ID: NCT02665338
Last Updated: 2022-08-17
Results Overview
During MRI scan in which participants will watch smoking picture, investigators will measure the change in neural activity in reward neural circuit. Whole brain imaging analysis and network analysis will be performed.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
7 days
Results posted on
2022-08-17
Participant Flow
Participant milestones
| Measure |
Sham rTMS
The sham TMS system will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.
Transcranial Magnetic Stimulation
|
Active rTMS
Stimulation frequency for all active subjects: 10 Hertz - Pulse train duration (on time) 5 seconds, Inter-train interval (off time) 10 seconds (15 second cycle time), Power (intensity) level 100% rMT, Total 60 trains, 15 minutes, Total pulses 3000.
Transcranial Magnetic Stimulation
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Sham rTMS
The sham TMS system will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.
Transcranial Magnetic Stimulation
|
Active rTMS
Stimulation frequency for all active subjects: 10 Hertz - Pulse train duration (on time) 5 seconds, Inter-train interval (off time) 10 seconds (15 second cycle time), Power (intensity) level 100% rMT, Total 60 trains, 15 minutes, Total pulses 3000.
Transcranial Magnetic Stimulation
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
One subject did not complete all study.
Baseline characteristics by cohort
| Measure |
Sham rTMS
n=5 Participants
The sham TMS system will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.
Transcranial Magnetic Stimulation
|
Active rTMS
n=6 Participants
Stimulation frequency for all active subjects: 10 Hertz - Pulse train duration (on time) 5 seconds, Inter-train interval (off time) 10 seconds (15 second cycle time), Power (intensity) level 100% rMT, Total 60 trains, 15 minutes, Total pulses 3000.
Transcranial Magnetic Stimulation
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • One subject did not complete all study.
|
0 Participants
n=7 Participants • One subject did not complete all study.
|
0 Participants
n=5 Participants • One subject did not complete all study.
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants • One subject did not complete all study.
|
6 Participants
n=7 Participants • One subject did not complete all study.
|
11 Participants
n=5 Participants • One subject did not complete all study.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants • One subject did not complete all study.
|
0 Participants
n=7 Participants • One subject did not complete all study.
|
0 Participants
n=5 Participants • One subject did not complete all study.
|
|
Age, Continuous
|
38.0 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
41.1 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
39.7 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: Effect of rTMS on Cue-induced Brain Activity: Left accumbens and Right medial orbital frontal cortex.
During MRI scan in which participants will watch smoking picture, investigators will measure the change in neural activity in reward neural circuit. Whole brain imaging analysis and network analysis will be performed.
Outcome measures
| Measure |
Sham rTMS
n=5 Participants
The sham TMS system will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.
Transcranial Magnetic Stimulation
|
Active rTMS
n=5 Participants
Stimulation frequency for all active subjects: 10 Hertz - Pulse train duration (on time) 5 seconds, Inter-train interval (off time) 10 seconds (15 second cycle time), Power (intensity) level 100% rMT, Total 60 trains, 15 minutes, Total pulses 3000.
Transcranial Magnetic Stimulation
|
|---|---|---|
|
Changes in fMRI Neural Activation Patterns
Left accumbens
|
0.14 % change
Standard Error 0.09
|
-0.38 % change
Standard Error 0.13
|
|
Changes in fMRI Neural Activation Patterns
Right medial orbital frontal cortex
|
0.13 % change
Standard Error 0.09
|
-0.22 % change
Standard Error 0.1
|
SECONDARY outcome
Timeframe: pre-TMS and post-TMS approx, 30 minutes.Population: The primary behavioral measure of cue craving was taken to be the contrast (difference) between active and sham rTMS in the pre- to post-experiment change in subjective craving. A two-factor mixed model (treatment: active vs sham) and (time: pre- vs post) were performed on cigarette-craving ratings.
visual analog scale for cue craving. Participants will be asked ' Right now, I would rate the amount of my craving to smoke as:'. The minimum score is 0, and the Maximum score is 7. There are 10 items. The total minimum score is 0, and the total maximum score is 70. A higher score is more craving to smoke a cigarette. The fewer values are considered to be a better outcome.
Outcome measures
| Measure |
Sham rTMS
n=5 Participants
The sham TMS system will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.
Transcranial Magnetic Stimulation
|
Active rTMS
n=5 Participants
Stimulation frequency for all active subjects: 10 Hertz - Pulse train duration (on time) 5 seconds, Inter-train interval (off time) 10 seconds (15 second cycle time), Power (intensity) level 100% rMT, Total 60 trains, 15 minutes, Total pulses 3000.
Transcranial Magnetic Stimulation
|
|---|---|---|
|
Reduction of Smoking Cue Craving
Pre-TMS
|
5.3 units on a scale
Standard Deviation 2.4
|
6.8 units on a scale
Standard Deviation 2.3
|
|
Reduction of Smoking Cue Craving
Post-TMS
|
6.5 units on a scale
Standard Deviation 2.1
|
6.4 units on a scale
Standard Deviation 2.4
|
Adverse Events
Sham rTMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active 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 |
Sham rTMS
n=5 participants at risk
The sham TMS system will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.
Transcranial Magnetic Stimulation
|
Active rTMS
n=6 participants at risk
Stimulation frequency for all active subjects: 10 Hertz - Pulse train duration (on time) 5 seconds, Inter-train interval (off time) 10 seconds (15 second cycle time), Power (intensity) level 100% rMT, Total 60 trains, 15 minutes, Total pulses 3000.
Transcranial Magnetic Stimulation
|
|---|---|---|
|
Nervous system disorders
discomfort on head
|
0.00%
0/5 • 7 days.
During TMS treatment sessions, participants can feel pain, unpleasantness, or headache.
|
16.7%
1/6 • Number of events 1 • 7 days.
During TMS treatment sessions, participants can feel pain, unpleasantness, or headache.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place