Trial Outcomes & Findings for Accelerated rTMS for the Reduction of Nicotine Craving (NCT NCT03352609)
NCT ID: NCT03352609
Last Updated: 2019-10-15
Results Overview
Percent of participants completing the 5 session rTMS course. Hypothesize \>75% of participants will complete the 5 treatments.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
1 day (single visit)
Results posted on
2019-10-15
Participant Flow
Participant milestones
| Measure |
Active rTMS
5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session.
Active rTMS with MagVenture MagPro double blind rTMS system: 5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session.
|
Sham
5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention.
Sham rTMS: Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Active rTMS
n=2 Participants
5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session.
Active rTMS with MagVenture MagPro double blind rTMS system: 5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session.
|
Sham
n=3 Participants
5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention.
Sham rTMS: Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=5 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
2 participants
n=2 Participants
|
3 participants
n=3 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 day (single visit)Percent of participants completing the 5 session rTMS course. Hypothesize \>75% of participants will complete the 5 treatments.
Outcome measures
| Measure |
Active rTMS
n=2 Participants
5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session.
Active rTMS with MagVenture MagPro double blind rTMS system: 5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session.
|
Sham
n=3 Participants
5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention.
Sham rTMS: Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads
|
|---|---|---|
|
Tolerability Measured by Percent of Participants Completing the rTMS Course
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: During the one day visitNicotine craving evaluated using Questionnaire on Smoking Urges- Brief (QSU-B) questions modified to a 0-100 analog rating. Higher scores meaning a higher level of craving.
Outcome measures
| Measure |
Active rTMS
n=2 Participants
5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session.
Active rTMS with MagVenture MagPro double blind rTMS system: 5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session.
|
Sham
n=3 Participants
5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention.
Sham rTMS: Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads
|
|---|---|---|
|
Decrease in Cue Induced Nicotine Craving
|
-4.65 Percent change on craving scale
Interval -10.0 to 0.7
|
-7.6 Percent change on craving scale
Interval -21.3 to 3.3
|
SECONDARY outcome
Timeframe: 1 week and 2 weeks after rTMSPopulation: Participants did not return follow up phone call
An exploratory outcome will be the determination if participants receiving active rTMS report decreased levels of smoking 1 week and 2 weeks after rTMS course.
Outcome measures
Outcome data not reported
Adverse Events
Active rTMS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham
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 |
Active rTMS
n=2 participants at risk
5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session.
Active rTMS with MagVenture MagPro double blind rTMS system: 5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session.
|
Sham
n=3 participants at risk
5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention.
Sham rTMS: Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Slight scalp discomfort
|
50.0%
1/2 • Single visit of approximately 6 hours
|
0.00%
0/3 • Single visit of approximately 6 hours
|
|
General disorders
Mild Nausea
|
0.00%
0/2 • Single visit of approximately 6 hours
|
33.3%
1/3 • Single visit of approximately 6 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place