Trial Outcomes & Findings for Brain Stimulation For Cancer Smokers (NCT NCT03419741)
NCT ID: NCT03419741
Last Updated: 2022-05-13
Results Overview
How many cancer patients with smoking can be enrolled in 12 months?
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
12 months
Results posted on
2022-05-13
Participant Flow
Participant milestones
| Measure |
Active rTMS Treatment
Transcranial Magnetic Stimulation Clinical Research System will be used for the active rTMS treatment. 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% resting motor threshold, Total 60 trains, 15 minutes, Total pulses 3000 per day, 3000 x 5 = 15000 pulses for 5 sessions.
Transcranial Magnetic Stimulation Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
|
Sham rTMS Treatment
Transcranial Magnetic Stimulation Clinical Research System -sham TMS 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 Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
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|---|---|---|
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Overall Study
STARTED
|
5
|
6
|
|
Overall Study
Treated
|
4
|
4
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Active rTMS Treatment
Transcranial Magnetic Stimulation Clinical Research System will be used for the active rTMS treatment. 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% resting motor threshold, Total 60 trains, 15 minutes, Total pulses 3000 per day, 3000 x 5 = 15000 pulses for 5 sessions.
Transcranial Magnetic Stimulation Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
|
Sham rTMS Treatment
Transcranial Magnetic Stimulation Clinical Research System -sham TMS 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 Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Three participants did not show up for treatment.
Baseline characteristics by cohort
| Measure |
Active rTMS Treatment
n=5 Participants
Transcranial Magnetic Stimulation Clinical Research System will be used for the active rTMS treatment. 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% resting motor threshold, Total 60 trains, 15 minutes, Total pulses 3000 per day, 3000 x 5 = 15000 pulses for 5 sessions.
Transcranial Magnetic Stimulation Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
|
Sham rTMS Treatment
n=6 Participants
Transcranial Magnetic Stimulation Clinical Research System -sham TMS 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 Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=6 Participants
|
6 Participants
n=11 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=11 Participants
|
|
Age, Continuous
|
63.25 years
n=5 Participants
|
64.5 years
n=6 Participants
|
63.9 years
n=11 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=6 Participants
|
9 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=6 Participants
|
11 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants • Three participants did not show up for treatment.
|
0 Participants
n=4 Participants • Three participants did not show up for treatment.
|
0 Participants
n=8 Participants • Three participants did not show up for treatment.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants • Three participants did not show up for treatment.
|
0 Participants
n=4 Participants • Three participants did not show up for treatment.
|
0 Participants
n=8 Participants • Three participants did not show up for treatment.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants • Three participants did not show up for treatment.
|
0 Participants
n=4 Participants • Three participants did not show up for treatment.
|
0 Participants
n=8 Participants • Three participants did not show up for treatment.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants • Three participants did not show up for treatment.
|
1 Participants
n=4 Participants • Three participants did not show up for treatment.
|
1 Participants
n=8 Participants • Three participants did not show up for treatment.
|
|
Race (NIH/OMB)
White
|
4 Participants
n=4 Participants • Three participants did not show up for treatment.
|
3 Participants
n=4 Participants • Three participants did not show up for treatment.
|
7 Participants
n=8 Participants • Three participants did not show up for treatment.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants • Three participants did not show up for treatment.
|
0 Participants
n=4 Participants • Three participants did not show up for treatment.
|
0 Participants
n=8 Participants • Three participants did not show up for treatment.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants • Three participants did not show up for treatment.
|
0 Participants
n=4 Participants • Three participants did not show up for treatment.
|
0 Participants
n=8 Participants • Three participants did not show up for treatment.
|
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Cigarette per day = the number of smoked cigarettes per 24 hours
|
15 cigarettes
n=5 Participants
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10 cigarettes
n=6 Participants
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13 cigarettes
n=11 Participants
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PRIMARY outcome
Timeframe: 12 monthsHow many cancer patients with smoking can be enrolled in 12 months?
Outcome measures
| Measure |
Active rTMS Treatment
n=4 Participants
Transcranial Magnetic Stimulation Clinical Research System will be used for the active rTMS treatment. 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% resting motor threshold, Total 60 trains, 15 minutes, Total pulses 3000 per day, 3000 x 5 = 15000 pulses for 5 sessions.
Transcranial Magnetic Stimulation Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
|
Sham rTMS Treatment
n=4 Participants
Transcranial Magnetic Stimulation Clinical Research System -sham TMS 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 Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
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|---|---|---|
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The Number of Enrollment
|
4 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 5 daysTotal number of smoke-free days during a day quit attempt. Self-reported abstinence during the day quit attempt will be assessed via timeline. The maximum number of consecutive days of abstinence will be recorded. Participants who does not report at least one 24-hour period of abstinence will be recorded as "0" days abstinent.
Outcome measures
| Measure |
Active rTMS Treatment
n=4 Participants
Transcranial Magnetic Stimulation Clinical Research System will be used for the active rTMS treatment. 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% resting motor threshold, Total 60 trains, 15 minutes, Total pulses 3000 per day, 3000 x 5 = 15000 pulses for 5 sessions.
Transcranial Magnetic Stimulation Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
|
Sham rTMS Treatment
n=4 Participants
Transcranial Magnetic Stimulation Clinical Research System -sham TMS 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 Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
|
|---|---|---|
|
Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on the Number of Abstinence Days.
|
0 days
|
0 days
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysthe change of self-reported number of cigarettes smoked per day
Outcome measures
| Measure |
Active rTMS Treatment
n=3 Participants
Transcranial Magnetic Stimulation Clinical Research System will be used for the active rTMS treatment. 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% resting motor threshold, Total 60 trains, 15 minutes, Total pulses 3000 per day, 3000 x 5 = 15000 pulses for 5 sessions.
Transcranial Magnetic Stimulation Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
|
Sham rTMS Treatment
n=4 Participants
Transcranial Magnetic Stimulation Clinical Research System -sham TMS 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 Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
|
|---|---|---|
|
Effect of rTMS on Cigarette Consumption
|
12.17 number of cigarettes
Standard Error 1.48
|
11.29 number of cigarettes
Standard Error 1.71
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysBrief questionnaire of smoking urges - brief (QSU - Brief) is used to assess smoking urges. Ten questions are included in the test. Range of scales is 1-7 score for each item. The cue craving scales include 10 items. The range of the total score is 10- 70 score. The maximum number means the highest craving that is the worst outcome. The minimum number is the least craving for cigarettes that is the best outcome.
Outcome measures
| Measure |
Active rTMS Treatment
n=3 Participants
Transcranial Magnetic Stimulation Clinical Research System will be used for the active rTMS treatment. 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% resting motor threshold, Total 60 trains, 15 minutes, Total pulses 3000 per day, 3000 x 5 = 15000 pulses for 5 sessions.
Transcranial Magnetic Stimulation Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
|
Sham rTMS Treatment
n=4 Participants
Transcranial Magnetic Stimulation Clinical Research System -sham TMS 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 Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
|
|---|---|---|
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Effect of rTMS on Cue Craving to Smoke Cigarette
Session 5
|
25.6 score on a scale
Standard Deviation 24.1
|
32.8 score on a scale
Standard Deviation 44.7
|
|
Effect of rTMS on Cue Craving to Smoke Cigarette
Session 1
|
45.3 score on a scale
Standard Deviation 24.9
|
36.0 score on a scale
Standard Deviation 43.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysThe change of visual analog scale (VAS). The VAS has 1-7 score. The minimum is 1 which means the best result. The maximum value of 7 is the worst outcome. The VAS was measured during 5 treatment sessions.
Outcome measures
| Measure |
Active rTMS Treatment
n=3 Participants
Transcranial Magnetic Stimulation Clinical Research System will be used for the active rTMS treatment. 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% resting motor threshold, Total 60 trains, 15 minutes, Total pulses 3000 per day, 3000 x 5 = 15000 pulses for 5 sessions.
Transcranial Magnetic Stimulation Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
|
Sham rTMS Treatment
n=4 Participants
Transcranial Magnetic Stimulation Clinical Research System -sham TMS 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 Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
|
|---|---|---|
|
Effect of rTMS on Cue Craving to Smoke Cigarette
Session 1
|
5.2 score on a scale
Standard Deviation 2.1
|
3.8 score on a scale
Standard Deviation 2.9
|
|
Effect of rTMS on Cue Craving to Smoke Cigarette
Session 5
|
3.7 score on a scale
Standard Deviation 3.2
|
3.5 score on a scale
Standard Deviation 3.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysSide effect will be measured pre and post each rTMS session.
Outcome measures
| Measure |
Active rTMS Treatment
n=4 Participants
Transcranial Magnetic Stimulation Clinical Research System will be used for the active rTMS treatment. 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% resting motor threshold, Total 60 trains, 15 minutes, Total pulses 3000 per day, 3000 x 5 = 15000 pulses for 5 sessions.
Transcranial Magnetic Stimulation Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
|
Sham rTMS Treatment
n=4 Participants
Transcranial Magnetic Stimulation Clinical Research System -sham TMS 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 Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
|
|---|---|---|
|
Adverse Events
|
2 number of events
|
0 number of events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: One dropped out of the study.
How many subjects completed treatment and a 30 days follow-up.
Outcome measures
| Measure |
Active rTMS Treatment
n=4 Participants
Transcranial Magnetic Stimulation Clinical Research System will be used for the active rTMS treatment. 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% resting motor threshold, Total 60 trains, 15 minutes, Total pulses 3000 per day, 3000 x 5 = 15000 pulses for 5 sessions.
Transcranial Magnetic Stimulation Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
|
Sham rTMS Treatment
n=4 Participants
Transcranial Magnetic Stimulation Clinical Research System -sham TMS 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 Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
|
|---|---|---|
|
Study Attrition Rate
|
1 participants
|
0 participants
|
Adverse Events
Active rTMS Treatment
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham rTMS Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active rTMS Treatment
n=4 participants at risk
Transcranial Magnetic Stimulation Clinical Research System will be used for the active rTMS treatment. 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% resting motor threshold, Total 60 trains, 15 minutes, Total pulses 3000 per day, 3000 x 5 = 15000 pulses for 5 sessions.
Transcranial Magnetic Stimulation Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
|
Sham rTMS Treatment
n=4 participants at risk
Transcranial Magnetic Stimulation Clinical Research System -sham TMS 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 Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
|
|---|---|---|
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Respiratory, thoracic and mediastinal disorders
confusional state
|
25.0%
1/4 • Number of events 1 • Adverse Event data will be collected throughout the course of the treatment part of the study, up to 30 days. We estimated adverse events through study completion, an average of 30 days.
Adverse events include headache and pain on the stimulation site.
|
0.00%
0/4 • Adverse Event data will be collected throughout the course of the treatment part of the study, up to 30 days. We estimated adverse events through study completion, an average of 30 days.
Adverse events include headache and pain on the stimulation site.
|
Other adverse events
| Measure |
Active rTMS Treatment
n=4 participants at risk
Transcranial Magnetic Stimulation Clinical Research System will be used for the active rTMS treatment. 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% resting motor threshold, Total 60 trains, 15 minutes, Total pulses 3000 per day, 3000 x 5 = 15000 pulses for 5 sessions.
Transcranial Magnetic Stimulation Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
|
Sham rTMS Treatment
n=4 participants at risk
Transcranial Magnetic Stimulation Clinical Research System -sham TMS 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 Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
|
|---|---|---|
|
Nervous system disorders
taste change
|
25.0%
1/4 • Number of events 1 • Adverse Event data will be collected throughout the course of the treatment part of the study, up to 30 days. We estimated adverse events through study completion, an average of 30 days.
Adverse events include headache and pain on the stimulation site.
|
0.00%
0/4 • Adverse Event data will be collected throughout the course of the treatment part of the study, up to 30 days. We estimated adverse events through study completion, an average of 30 days.
Adverse events include headache and pain on the stimulation site.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place