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Trial record 30 of 1364 for:    transcranial magnetic stimulation

Repetitive Transcranial Magnetic Stimulation to Reduce Tics

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ClinicalTrials.gov Identifier: NCT01258790
Recruitment Status : Completed
First Posted : December 13, 2010
Results First Posted : July 1, 2014
Last Update Posted : July 1, 2014
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Tourette Syndrome
Interventions Device: Sham Repetitive Transcranial Magnetic Stimulation
Device: Active Repetitive Transcranial Magnetic Stimulation
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Repetitive Transcranial Magnetic Stimulation Sham Repetitive Transcranial Magnetic Stimulation
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 6 6
Completed 6 6
Not Completed 0 0
Arm/Group Title Active Repetitive Transcranial Magnetic Stimulation Sham Repetitive Transcranial Magnetic Stimulation Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
13.5  (3.9) 15.5  (4) 14.5  (3.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
0
   0.0%
3
  50.0%
3
  25.0%
Male
6
 100.0%
3
  50.0%
9
  75.0%
Yale Global Tic Severity Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale (0 - 50)
Number Analyzed 6 participants 6 participants 12 participants
27.5  (7.4) 26.8  (4.8) 27.2  (6.0)
[1]
Measure Description: 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.
1.Primary Outcome
Title Yale Global Tic Severity Scale
Hide Description 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.
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Repetitive Transcranial Magnetic Stimulation Sham Repetitive Transcranial Magnetic Stimulation
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: units on a scale (0 - 50)
23.2  (9.8) 21.7  (7.7)
Time Frame [Not Specified]
Adverse Event Reporting Description Systematic assessment for adverse events was performed using a 16-item Review of Systems.
 
Arm/Group Title Active Repetitive Transcranial Magnetic Stimulation Sham Repetitive Transcranial Magnetic Stimulation
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Active Repetitive Transcranial Magnetic Stimulation Sham Repetitive Transcranial Magnetic Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Active Repetitive Transcranial Magnetic Stimulation Sham Repetitive Transcranial Magnetic Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Repetitive Transcranial Magnetic Stimulation Sham Repetitive Transcranial Magnetic Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   2/6 (33.33%)   1/6 (16.67%) 
Gastrointestinal disorders     
Mild abdominal discomfort   1/6 (16.67%)  0/6 (0.00%) 
Nervous system disorders     
Mild headache   1/6 (16.67%)  1/6 (16.67%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Steve Wu, MD
Organization: Cincinnati Children's Hospital Medical Center
Phone: 513-636-4222
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01258790     History of Changes
Other Study ID Numbers: IRB #: 2010-2689
First Submitted: December 10, 2010
First Posted: December 13, 2010
Results First Submitted: March 25, 2014
Results First Posted: July 1, 2014
Last Update Posted: July 1, 2014