Repetitive Transcranial Magnetic Stimulation for the Treatment of Focal Hand Dystonia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01884064|
Recruitment Status : Completed
First Posted : June 21, 2013
Results First Posted : November 2, 2015
Last Update Posted : June 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Dystonia, Focal, Task-specific||Device: rTMS Device: Sham rTMS||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multiple Sessions of Low-frequency Repetitive Transcranial Magnetic Stimulation in Focal Hand Dystonia: Clinical and Physiological Effects|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||July 2010|
Experimental: inhibitory rTMS
Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex. Patients held a pencil and made movements that did not elicit dystonic symptoms during rTMS. Intervention was delivered every day for 5 days.
Other Name: Magstim Rapid 2, Magstim Co, Whitland Dyfed, UK
Placebo Comparator: Sham rTMS
Sham Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex. Patients held a pencil and made movements that did not elicit dystonic symptoms during rTMS. Intervention was delivered every day for 5 days.
Device: Sham rTMS
Other Name: Placebo Magstim Rapid 2, Magstim Co, Whitland Dyfed, UK
- Cortical Silent Period [ Time Frame: Baseline and Day 5 ]Subjects performed an isometric abduction contraction of the index finger against a strain gauge coupled to a load cell. A single TMS pulse was applied 2-3 s after contraction initiation and subjects were instructed to relax 2-3 s after stimulation. The duration of the CSP was measured on a trial-by-trial basis and was delineated by the first superimposed TMS-evoked EMG spike (onset) and the return of activity to 50% of prestimulus EMG signal (offset). The mean CSP duration was calculated for each block of measurements. The duration of CSP is thought to be related to intracortical GABAergic synapse-mediated inhibition in the stimulated cortical region. Measures of CSP have been shown to be reliable in repeated measures studies to determine an effect of intervention within a group of subjects (Orth and Rothwell 2004; Borich et al., 2009). Values are calculated as the value recorded at the latest time minus the earliest time point.
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): NCT01884064
|United States, Minnesota|
|Program in Physical Therapy, University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Teresa J Kimberley, PhD, PT||University of Minnesota - Clinical and Translational Science Institute|