Transcranial Magnetic Stimulation (TMS) for Individuals With Tourette's Syndrome
NCT ID: NCT00529308
Last Updated: 2019-02-21
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
20 participants
Study Classification
INTERVENTIONAL
Study Start Date
2007-07-31
Study Completion Date
2011-07-31
Brief Summary
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This study will evaluate the clinical efficacy of 1 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the supplementary motor area (SMA) in Tourette's Syndrome (TS) patients who have not fully responded to conventional therapies. The investigators will collect TMS measures of motor cortex excitability to test whether rTMS restores normal levels of intracortical inhibition found to be deficient in TS. The investigators will administer neuropsychological tests to demonstrate that SMA targeted rTMS can be administered safely without significant impairments of cognitive or motor functioning. The investigators hypothesize that:
1. Compared to sham (placebo), active rTMS will improve symptoms of TS as assessed with the Yale Global Tic Severity Scale (Y-GTSS) and Clinical Global Impression (CGI).
2. Active (but not sham) rTMS will normalize levels of motor cortex excitability, as reflected by increased intracortical inhibition, motor threshold, and cortical silent period, and by decreased intracortical facilitation, relative to pre-treatment baseline.
1. Compared to sham (placebo), active rTMS will improve symptoms of TS as assessed with the Yale Global Tic Severity Scale (Y-GTSS) and Clinical Global Impression (CGI).
2. Active (but not sham) rTMS will normalize levels of motor cortex excitability, as reflected by increased intracortical inhibition, motor threshold, and cortical silent period, and by decreased intracortical facilitation, relative to pre-treatment baseline.
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Detailed Description
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This study tests the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) in the treatment of Tourette's Syndrome (TS). It also examines measures of brain function to study the brain basis underlying TS.
Despite major advances in the study and treatment of TS, patients often do not experience full remission from pharmacotherapy or behavioral therapy (Leckman 2002). rTMS is a non-invasive procedure that stimulates the brain using magnetic fields. This pilot study reported that rTMS may reduce TS symptoms (Mantovani et al., 2006). While promising, prior research has several limitations (e.g., relatively small sample sizes, and lack of sham \[placebo\] comparison).
This study addresses the drawbacks of prior work, and will provide data that will help to determine whether rTMS can be useful for TS patients resistant to conventional therapies. 25 outpatients with TS who have been only partially responsive to conventional therapies will be randomly assigned to either active low frequency (1 Hz) rTMS or sham (placebo) stimulation. The active or sham stimulation will be applied to the supplementary motor area (SMA) daily for three weeks. If rTMS will be added onto ongoing pharmacotherapy, the doses must have been stable for four weeks prior to study entry. The SMA was selected because of its connections with brain areas implicated in TS. Pilot work indicates that stimulation of SMA with low frequency rTMS is beneficial in TS patients. Low frequency rTMS has the added benefit of a better safety profile (i.e. no risk of seizure) than high frequency rTMS.
Rating scales for symptom change will be obtained at baseline, during the rTMS course, and at the end of three weeks of treatment. Patients will then be offered an open-label cross-over phase for an additional three weeks of daily active rTMS treatment. Patients who meet remission criteria in either phase or response criteria following the cross-over phase will continue routine clinical care under the supervision of their treating psychiatrist and will be invited back for assessment at 1, 3, and 6 months to determine the persistence of benefit.
Excitability of the motor cortex has been reported to be abnormal in TS, and may relate to dysfunction in motor pathways. We will collect measures of motor cortex excitability (with single and paired-pulse TMS) at baseline and after each phase to study whether changes in these measures may be correlated with clinical improvement.
Despite major advances in the study and treatment of TS, patients often do not experience full remission from pharmacotherapy or behavioral therapy (Leckman 2002). rTMS is a non-invasive procedure that stimulates the brain using magnetic fields. This pilot study reported that rTMS may reduce TS symptoms (Mantovani et al., 2006). While promising, prior research has several limitations (e.g., relatively small sample sizes, and lack of sham \[placebo\] comparison).
This study addresses the drawbacks of prior work, and will provide data that will help to determine whether rTMS can be useful for TS patients resistant to conventional therapies. 25 outpatients with TS who have been only partially responsive to conventional therapies will be randomly assigned to either active low frequency (1 Hz) rTMS or sham (placebo) stimulation. The active or sham stimulation will be applied to the supplementary motor area (SMA) daily for three weeks. If rTMS will be added onto ongoing pharmacotherapy, the doses must have been stable for four weeks prior to study entry. The SMA was selected because of its connections with brain areas implicated in TS. Pilot work indicates that stimulation of SMA with low frequency rTMS is beneficial in TS patients. Low frequency rTMS has the added benefit of a better safety profile (i.e. no risk of seizure) than high frequency rTMS.
Rating scales for symptom change will be obtained at baseline, during the rTMS course, and at the end of three weeks of treatment. Patients will then be offered an open-label cross-over phase for an additional three weeks of daily active rTMS treatment. Patients who meet remission criteria in either phase or response criteria following the cross-over phase will continue routine clinical care under the supervision of their treating psychiatrist and will be invited back for assessment at 1, 3, and 6 months to determine the persistence of benefit.
Excitability of the motor cortex has been reported to be abnormal in TS, and may relate to dysfunction in motor pathways. We will collect measures of motor cortex excitability (with single and paired-pulse TMS) at baseline and after each phase to study whether changes in these measures may be correlated with clinical improvement.
Conditions
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Tourette Syndrome
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
Study Groups
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Active
Group Type
ACTIVE_COMPARATOR
Transcranial Magnetic Stimulation (active)
Intervention Type
DEVICE
Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
Sham
Group Type
SHAM_COMPARATOR
Transcranial Magnetic Stimulation (sham)
Intervention Type
DEVICE
Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
Interventions
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Transcranial Magnetic Stimulation (active)
Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
Intervention Type
DEVICE
Transcranial Magnetic Stimulation (sham)
Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
Intervention Type
DEVICE
Other Intervention Names
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Magstim Rapid2
Magstim Rapid2
Eligibility Criteria
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Inclusion Criteria
* Primary diagnosis of Tourette's Syndrome, as confirmed by the DSM-IV-TR criteria
* Residual TS symptoms, defined as a total Y-GTSS total motor tic or phonic tic score \> 20, despite treatment with an adequate trial of medications (defined as a failure to respond to a trial of commonly used medications for TS such as clonidine, guanfacine, or neuroleptic medications, given at recommended dosage and duration based on the clinician's judgment)
* Persistent high level of tic severity for 4 months despite efforts to control the tics using medications, or the presence of self injurious tics
* Duration of the index episode of at least a year
* Individuals who cannot tolerate medications of class and dose at the specified duration as described above will also be included
* Patients currently on medication must be at the same stable dose(s) for one month prior to enrollment and be willing to continue at the same dose(s) through the duration of the study
* Residual TS symptoms, defined as a total Y-GTSS total motor tic or phonic tic score \> 20, despite treatment with an adequate trial of medications (defined as a failure to respond to a trial of commonly used medications for TS such as clonidine, guanfacine, or neuroleptic medications, given at recommended dosage and duration based on the clinician's judgment)
* Persistent high level of tic severity for 4 months despite efforts to control the tics using medications, or the presence of self injurious tics
* Duration of the index episode of at least a year
* Individuals who cannot tolerate medications of class and dose at the specified duration as described above will also be included
* Patients currently on medication must be at the same stable dose(s) for one month prior to enrollment and be willing to continue at the same dose(s) through the duration of the study
Exclusion Criteria
* Individuals diagnosed with major depressive disorder (current) of moderate or severe intensity (CGI ≥ 4), bipolar disorder (lifetime), any psychotic disorder (lifetime), or an Axis II personality disorder; with a history of substance abuse or dependence within the past year (except nicotine and caffeine); or at significant acute suicide risk will be excluded
* Individuals with a clinically defined neurological disorder, with an increased risk of seizure for any reason, with a history of treatment with TMS, deep brain stimulation for any disorder will be excluded
* Patients with cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed will be excluded
* Current use of any investigational drug, any medications with proconvulsive action, such as bupropion, maprotiline, tricyclic antidepressant, clomipramine, classical antipsychotics, and daily use of any medications with a known inhibitory effect on cortical excitability measures (e.g., anticonvulsants, standing doses of benzodiazepines, sedative/hypnotics, and atypical antipsychotics) will not be permitted
* If participating in psychotherapy, patients must have been in stable treatment for at least three months prior to entry into the study, with no anticipation of change in frequency therapeutic sessions, or the therapeutic focus over the duration of the TMS trial
* Finally, current significant laboratory abnormality, known or suspected pregnancy, women who are breast-feeding or women of childbearing potential not using a medically accepted form of contraception when engaging in sexual intercourse will also be excluded.
* Individuals with a clinically defined neurological disorder, with an increased risk of seizure for any reason, with a history of treatment with TMS, deep brain stimulation for any disorder will be excluded
* Patients with cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed will be excluded
* Current use of any investigational drug, any medications with proconvulsive action, such as bupropion, maprotiline, tricyclic antidepressant, clomipramine, classical antipsychotics, and daily use of any medications with a known inhibitory effect on cortical excitability measures (e.g., anticonvulsants, standing doses of benzodiazepines, sedative/hypnotics, and atypical antipsychotics) will not be permitted
* If participating in psychotherapy, patients must have been in stable treatment for at least three months prior to entry into the study, with no anticipation of change in frequency therapeutic sessions, or the therapeutic focus over the duration of the TMS trial
* Finally, current significant laboratory abnormality, known or suspected pregnancy, women who are breast-feeding or women of childbearing potential not using a medically accepted form of contraception when engaging in sexual intercourse will also be excluded.
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Tourette Association of America
OTHER
Sponsor Role
collaborator
Yale University
OTHER
Sponsor Role
lead
Responsible Party
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Angeli Landeros-Weisenberger
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Antonio Mantovani, MD
Role: PRINCIPAL_INVESTIGATOR
New York State Psychiatric Institute
Locations
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Yale University School of Medicine
New Haven, Connecticut, United States
Site Status
New York State Psychiatric Institute
New York, New York, United States
Site Status
Countries
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United States
References
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BACKGROUND
Landeros-Weisenberger A, Mantovani A, Motlagh MG, de Alvarenga PG, Katsovich L, Leckman JF, Lisanby SH. Randomized Sham Controlled Double-blind Trial of Repetitive Transcranial Magnetic Stimulation for Adults With Severe Tourette Syndrome. Brain Stimul. 2015 May-Jun;8(3):574-81. doi: 10.1016/j.brs.2014.11.015. Epub 2014 Dec 3.
Reference Type
DERIVED
Related Links
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http://www.brainstimulation.columbia.edu/research/clinical/tourette.html
Study summary on Brain Stimulation Division web site
Other Identifiers
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5480
Identifier Type: -
Identifier Source: org_study_id
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COMPLETED
NA
Thalamic Deep Brain Stimulation for Tourette Syndrome
NCT00311909
COMPLETED
PHASE2
Transcranial Magnetic Stimulation (TMS) and Obsessive Compulsive Disorder (OCD)
NCT00106249
COMPLETED
PHASE2
tDCS in Tourette (TIC-TDCS)
NCT03401996
UNKNOWN
NA
Effects of rTMS on Human Brain Activity
NCT04242810
WITHDRAWN
NA
Repetitive Transcranial Magnetic Stimulation Therapy in Essential Tremor
NCT06145932
RECRUITING
NA
Transcranial Magnetic Stimulation (TMS) Study for Adults With Autism Spectrum Disorder (ASD)
NCT04936009
RECRUITING
NA
Tourette Syndrome Deep Brain Stimulation
NCT02056873
COMPLETED
NA
Brain Stimulation for the Treatment of Tourette Syndrome
NCT01329198
COMPLETED
NA
Transcranial Magnetic Stimulation (rTMS) and Autism.
NCT01648868
COMPLETED
NA
Transcranial Stimulation for Essential Tremor
NCT03025529
TERMINATED
NA
Repetitive Transcranial Magnetic Stimulation (rTMS) for Dystonia and Tremor
NCT04299087
COMPLETED
NA
Transcranial Magnetic Stimulation in Children With Attention Deficit Hyperactivity Disorder (ADHD). A Safety Study
NCT01052064
UNKNOWN
PHASE1
Repetitive Transcranial Magnetic Stimulation for the Treatment of the Tardive Dyskinesia.
NCT02840760
UNKNOWN
NA
Thalamic Deep Brain Stimulation for the Treatment of Refractory Tourette Syndrome
NCT01817517
TERMINATED
NA
Thalamic Deep Brain Stimulation for Tourette Syndrome
NCT03958617
COMPLETED
PHASE2/PHASE3