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Repetitive Transcranial Magnetic Stimulation for the Treatment of Focal Hand Dystonia

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ClinicalTrials.gov Identifier: NCT01884064
Recruitment Status : Completed
First Posted : June 21, 2013
Results First Posted : November 2, 2015
Last Update Posted : June 17, 2016
Sponsor:
Collaborators:
Dystonia Medical Research Foundation
National Institutes of Health (NIH)
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Dystonia, Focal, Task-specific
Interventions Device: rTMS
Device: Sham rTMS
Enrollment 17

Recruitment Details  
Pre-assignment Details  
Arm/Group Title rTMS Sham rTMS
Hide Arm/Group Description

Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.

rTMS: rTMS

Sham or Placebo Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.

rTMS: rTMS

Period Title: Overall Study
Started 12 5
Completed 12 5
Not Completed 0 0
Arm/Group Title rTMS Sham rTMS Total
Hide Arm/Group Description

Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.

rTMS: rTMS

Sham Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.

Sham rTMS: Sham rTMS

Total of all reporting groups
Overall Number of Baseline Participants 12 5 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 5 participants 17 participants
46.5  (12.4) 46.6  (14.8) 46.5  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 5 participants 17 participants
Female
5
  41.7%
2
  40.0%
7
  41.2%
Male
7
  58.3%
3
  60.0%
10
  58.8%
1.Primary Outcome
Title Cortical Silent Period
Hide Description 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.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title rTMS Sham rTMS
Hide Arm/Group Description:

Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.

rTMS: rTMS

Sham or Placebo Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.

rTMS: rTMS

Overall Number of Participants Analyzed 12 5
Mean (Standard Deviation)
Unit of Measure: milliseconds
9  (6.9) 1.61  (15.7)
Time Frame Before and after each session of the intervention
Adverse Event Reporting Description Subjects were asked to report any adverse event
 
Arm/Group Title rTMS Sham rTMS
Hide Arm/Group Description

Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.

rTMS: rTMS

Sham or Placebo Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.

rTMS: rTMS

All-Cause Mortality
rTMS Sham rTMS
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
rTMS Sham rTMS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
rTMS Sham rTMS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/12 (25.00%)      0/5 (0.00%)    
Psychiatric disorders     
Mild Headache *  2/12 (16.67%)  2 0/5 (0.00%)  0
Fatigue *  1/12 (8.33%)  1 0/5 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
In this preliminary study, there were subjects with different types of hand dystonia and large range of symptom duration. An ideal study would have sufficient n to be able to stratify subjects within various groups.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Teresa Jacobson Kimberley
Organization: University of Minnesota
Phone: 612-626-4096
EMail: tjk@umn.edu
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01884064     History of Changes
Other Study ID Numbers: 0608M91226
M01RR000400 ( U.S. NIH Grant/Contract )
First Submitted: June 20, 2012
First Posted: June 21, 2013
Results First Submitted: August 17, 2015
Results First Posted: November 2, 2015
Last Update Posted: June 17, 2016