Trial Outcomes & Findings for Repetitive Transcranial Magnetic Stimulation to Reduce Tics (NCT NCT01258790)
NCT ID: NCT01258790
Last Updated: 2014-07-01
Results Overview
The tic severity score based on Yale Global Tic Severity Scale ranges from 0 - 50. A person who has no tics would have a score of 0. High score means a person has severe tics.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
1 week
Results posted on
2014-07-01
Participant Flow
Participant milestones
| Measure |
Active Repetitive Transcranial Magnetic Stimulation
In the active arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
|
Sham Repetitive Transcranial Magnetic Stimulation
In the sham arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim sham 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Repetitive Transcranial Magnetic Stimulation to Reduce Tics
Baseline characteristics by cohort
| Measure |
Active Repetitive Transcranial Magnetic Stimulation
n=6 Participants
In the active arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
|
Sham Repetitive Transcranial Magnetic Stimulation
n=6 Participants
In the sham arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim sham 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.5 years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
15.5 years
STANDARD_DEVIATION 4 • n=7 Participants
|
14.5 years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Yale Global Tic Severity Scale
|
27.5 units on a scale (0 - 50)
STANDARD_DEVIATION 7.4 • n=5 Participants
|
26.8 units on a scale (0 - 50)
STANDARD_DEVIATION 4.8 • n=7 Participants
|
27.2 units on a scale (0 - 50)
STANDARD_DEVIATION 6.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 weekThe tic severity score based on Yale Global Tic Severity Scale ranges from 0 - 50. A person who has no tics would have a score of 0. High score means a person has severe tics.
Outcome measures
| Measure |
Active Repetitive Transcranial Magnetic Stimulation
n=6 Participants
In the active arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
|
Sham Repetitive Transcranial Magnetic Stimulation
n=6 Participants
In the sham arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim sham 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
|
|---|---|---|
|
Yale Global Tic Severity Scale
|
23.2 units on a scale (0 - 50)
Standard Deviation 9.8
|
21.7 units on a scale (0 - 50)
Standard Deviation 7.7
|
Adverse Events
Active Repetitive Transcranial Magnetic Stimulation
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Sham Repetitive Transcranial Magnetic Stimulation
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 Repetitive Transcranial Magnetic Stimulation
n=6 participants at risk
In the active arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
|
Sham Repetitive Transcranial Magnetic Stimulation
n=6 participants at risk
In the sham arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim sham 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
|
|---|---|---|
|
Nervous system disorders
Mild headache
|
16.7%
1/6
Systematic assessment for adverse events was performed using a 16-item Review of Systems.
|
16.7%
1/6
Systematic assessment for adverse events was performed using a 16-item Review of Systems.
|
|
Gastrointestinal disorders
Mild abdominal discomfort
|
16.7%
1/6
Systematic assessment for adverse events was performed using a 16-item Review of Systems.
|
0.00%
0/6
Systematic assessment for adverse events was performed using a 16-item Review of Systems.
|
Additional Information
Steve Wu, MD
Cincinnati Children's Hospital Medical Center
Phone: 513-636-4222
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place