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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
rTMS

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 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


Participant Flow:   Overall Study
    rTMS   Sham rTMS
STARTED   12   5 
COMPLETED   12   5 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
rTMS

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 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 Total of all reporting groups

Baseline Measures
   rTMS   Sham rTMS   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   5   17 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.5  (12.4)   46.6  (14.8)   46.5  (12.4) 
Gender 
[Units: Participants]
     
Female   5   2   7 
Male   7   3   10 


  Outcome Measures

1.  Primary:   Cortical Silent Period   [ Time Frame: Baseline and Day 5 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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
e-mail: tjk@umn.edu


Publications of Results:

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