Repetitive Magnetic Transcranial Stimulation (rTMS) in the Treatment of Generalized Anxiety Disorder (GAD)
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|ClinicalTrials.gov Identifier: NCT00662584|
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : August 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Generalized Anxiety Disorder||Procedure: Repetitive transcranial magnetic stimulation (rTMS)||Phase 3|
This study utilized a 3-week open-label design to evaluate the efficacy of fMRI guided rTMS in the treatment of GAD.
We first used functional magnetic resonance imaging (fMRI) during the gambling task to localize anxiety-related brain activations in each individual participant, and then used this information to guide treatment with repetitive transcranial magnetic stimulation (rTMS).
TMS was delivered to the target site at a frequency of 1 Hz for 20 minutes (900 total pulses). The intensity of the TMS was set to 90% of the passive motor threshold for each participant.
The primary efficacy measures include the Clinical Global Impression of Improvement (CGI-I) and the Hamilton Anxiety Rating Scale (HARS). Response to treatment was defined as a reduction of 50% or more on the HARS and symptom remission was defined as a CGI-I score of 1 or 2 ("much improved" or "very much improved" respectively) and a score ≤ 8 on the HARS. Data was entered anonymously into an Excel spreadsheet and analyzed by the UCLA Semel Institute Statistical Core. The analysis was done on the intent to treat sample using last observation carried forward (LOCF). A one-sample paired t-test was used to compare endpoint to baseline means on the HARS, with a significance level set at p= 0.05, two-tailed.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy of Functional Magnetic Resonance Imaging (fMRI) Guided Low Frequency Repetitive Magnetic Transcranial Stimulation (rTMS) Therapy on Symptoms of Generalized Anxiety Disorder (GAD)|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||April 2007|
This was an open-label study - all subjects received the intervention (rTMS treatment)
Procedure: Repetitive transcranial magnetic stimulation (rTMS)
transcranial magnetic stimulation (TMS) at .5 HZ for 20s
- Structured Interview for the Hamilton Anxiety Rating Scale (SIGH-A) [ Time Frame: Week 0, 3, 6 ]
- The Clinical Global Impression (CGI) Scale of Severity/Improvement [ Time Frame: Week 0, 3, 6 ]
- Structured Interview for the Hamilton Depression Rating Scale (SIGH-D) [ Time Frame: Week 0 and 6 ]
- The Side-Effects Questionnaire [ Time Frame: Week 0, 3, 6 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00662584
|United States, California|
|Los Angeles, California, United States, 90024|
|Principal Investigator:||Alexander Bystritsky, MD||University of California, Los Angeles|