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Trial Outcomes & Findings for Transcranial Magnetic Stimulation (TMS) for Individuals With Tourette's Syndrome (NCT NCT00529308)

NCT ID: NCT00529308

Last Updated: 2019-02-21

Results Overview

Y-GTSS is a clinician-rated scale used to assess tic severity. Motor and phonic tics are rated separately from 0 to 5 on several scales including number, frequency, intensity, complexity, and interference. Thus Motor and Phonic Tic scores can range from 0 to 25; the combined Total Tic Score ranges from 0 to 50. There is also an Impairment score that rates the overall burden due to tics. The Impairment scale yields a single score from 0 to 50 with higher scores indicating higher levels of overall impairment associated with tics.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

3 weeks

Results posted on

2019-02-21

Participant Flow

Participant milestones

Participant milestones
Measure
Active rTMS
Sham
Overall Study
STARTED
9
11
Overall Study
COMPLETED
8
10
Overall Study
NOT COMPLETED
1
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Active rTMS
Sham
Overall Study
Withdrawal by Subject
1
1

Baseline Characteristics

Transcranial Magnetic Stimulation (TMS) for Individuals With Tourette's Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Active
n=9 Participants
Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
Sham
n=11 Participants
Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
Total
n=20 Participants
Total of all reporting groups
Age, Continuous
29.1 years
STANDARD_DEVIATION 7.4 • n=5 Participants
39.0 years
STANDARD_DEVIATION 16.1 • n=7 Participants
33.7 years
STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
9 Participants
n=7 Participants
16 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks

Y-GTSS is a clinician-rated scale used to assess tic severity. Motor and phonic tics are rated separately from 0 to 5 on several scales including number, frequency, intensity, complexity, and interference. Thus Motor and Phonic Tic scores can range from 0 to 25; the combined Total Tic Score ranges from 0 to 50. There is also an Impairment score that rates the overall burden due to tics. The Impairment scale yields a single score from 0 to 50 with higher scores indicating higher levels of overall impairment associated with tics.

Outcome measures

Outcome measures
Measure
Active
n=9 Participants
Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
Sham
n=11 Participants
Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
Yale Global Tic Severity Scale (Y-GTSS)
29.5 units on a scale
Standard Deviation 11.9
31.5 units on a scale
Standard Deviation 8.1

PRIMARY outcome

Timeframe: 3 weeks

Population: This data was only available for the subjects at the Yale site only.

Motor Threshold (MT) is thought to be a measure of membrane excitability in pyramidal neurons. MT is defined as the minimum magnetic flux needed to elicit a threshold EMG response (50 µV in peak to peak amplitude) in a resting target muscle in 5 out of 10 trials using single pulse TMS administered to the contralateral primary motor cortex. MT for both right and left hand are determined, and the lowest is used to select the intensity for rTMS.

Outcome measures

Outcome measures
Measure
Active
n=4 Participants
Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
Sham
n=9 Participants
Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
Motor Cortex Excitability Normalization-Right Motor Threshold
56 µV
Standard Deviation 16.3
59.8 µV
Standard Deviation 16.3

PRIMARY outcome

Timeframe: 3 weeks

The CGI-I is a clinician-rated scales that have been used in clinical trials for over 25 years. Clinicians rate patient improvement compared to baseline. By convention, 4 = No Change; scores of 5, 6, and 7 move in the direction of worsening; scores of 3, 2, and 1 correspond to "Minimal Improvement," "Much Improved" or "Very Much Improved," respectively. CGI-I ratings of "Much" or "Very Much Improved" at post-treatment are used to identify treatment responders.

Outcome measures

Outcome measures
Measure
Active
n=9 Participants
Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
Sham
n=11 Participants
Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
Number of Patients With "Much Improved or Very Much Improved" on Clinical Global Impression-Improvement (CGI) Scale
1 participants
0 participants

PRIMARY outcome

Timeframe: 3 weeks

Population: This data was only available for the subjects at the Yale site only.

Motor Threshold (MT) is thought to be a measure of membrane excitability in pyramidal neurons. MT is defined as the minimum magnetic flux needed to elicit a threshold EMG response (50 µV in peak to peak amplitude) in a resting target muscle in 5 out of 10 trials using single pulse TMS administered to the contralateral primary motor cortex. MT for both right and left hand are determined, and the lowest is used to select the intensity for rTMS.

Outcome measures

Outcome measures
Measure
Active
n=4 Participants
Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
Sham
n=9 Participants
Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
Motor Cortex Excitability Normalization-Left Motor Threshold
56.5 µV
Standard Deviation 12.8
63.8 µV
Standard Deviation 16.3

PRIMARY outcome

Timeframe: 3 weeks

The CGI-I is a clinician-rated scales that have been used in clinical trials for over 25 years. Clinicians rate patient improvement compared to baseline. By convention, 4 = No Change; scores of 5, 6, and 7 move in the direction of worsening; scores of 3, 2, and 1 correspond to "Minimal Improvement," "Much Improved" or "Very Much Improved," respectively. CGI-I ratings of "Much" or "Very Much Improved" at post-treatment are used to identify treatment responders.

Outcome measures

Outcome measures
Measure
Active
n=9 Participants
Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
Sham
n=11 Participants
Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
Number of Patients With "Improved or Minimally Improved" in Clinical Global Impression-Improvement (CGI) Scale
2 participants
8 participants

Adverse Events

Active

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Sham

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Active
n=8 participants at risk
Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
Sham
n=10 participants at risk
Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
Nervous system disorders
Headache
50.0%
4/8 • Adverse Events were collected throughout the duration of the study, which was approximately 4 years.
40.0%
4/10 • Adverse Events were collected throughout the duration of the study, which was approximately 4 years.
Musculoskeletal and connective tissue disorders
Neck Pain
25.0%
2/8 • Adverse Events were collected throughout the duration of the study, which was approximately 4 years.
90.0%
9/10 • Adverse Events were collected throughout the duration of the study, which was approximately 4 years.
Skin and subcutaneous tissue disorders
Scalp Pain
25.0%
2/8 • Adverse Events were collected throughout the duration of the study, which was approximately 4 years.
20.0%
2/10 • Adverse Events were collected throughout the duration of the study, which was approximately 4 years.
Nervous system disorders
Trouble Concentrating
0.00%
0/8 • Adverse Events were collected throughout the duration of the study, which was approximately 4 years.
10.0%
1/10 • Adverse Events were collected throughout the duration of the study, which was approximately 4 years.

Additional Information

Dr. Angeli Landeros-Weisenberger

Yale University

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place