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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

Tracking Information
First Submitted Date  ICMJE June 20, 2012
First Posted Date  ICMJE June 21, 2013
Results First Submitted Date  ICMJE August 17, 2015
Results First Posted Date  ICMJE November 2, 2015
Last Update Posted Date June 17, 2016
Study Start Date  ICMJE July 2008
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2013)
Change from baseline in cortical silent period [ Time Frame: Day 5: Post test after intervention. Also at day 15: Followup session 10 days after posttest ]
Cortical silence period
Change History Complete list of historical versions of study NCT01884064 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2013)
  • Change from baseline in hand writing assessment [ Time Frame: Day 5: Post test after intervention. Also at day 15: Followup session 10 days after posttest ]
    Hand writing assessment of pen pressure (reported in newtons)is a significant limitation for patients with hand dystonia. The efficacy of the intervention is tested with digitized table assessment of handwriting.
  • Change from baseline hand writing velocity [ Time Frame: Day 5: Post test after intervention. Also at day 15: Followup session 10 days after posttest ]
    Hand writing velocity (m/s)is a significant limitation for patients with hand dystonia. The efficacy of the intervention is tested with digitized table assessment of handwriting.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Repetitive Transcranial Magnetic Stimulation for the Treatment of Focal Hand Dystonia
Official Title  ICMJE Multiple Sessions of Low-frequency Repetitive Transcranial Magnetic Stimulation in Focal Hand Dystonia: Clinical and Physiological Effects
Brief Summary This study investigated the short term effects of repeated administrations of repetitive-transcranial magnetic stimulation (rTMS) on clinical changes and investigate neurophysiologic responses to rTMS of the activated motor system in patients with FHD.
Detailed Description Purpose: The ability of low-frequency repetitive transcranial magnetic stimulation (rTMS) to enhance intracortical inhibition has motivated its use as a potential therapeutic intervention in focal hand dystonia (FHD). In this preliminary investigation, we assessed the physiologic and behavioral effects of multiple sessions of rTMS in FHD. Methods: 12 patients with FHD underwent five daily-sessions of 1 Hz rTMS to contralateral dorsal premotor cortex (dPMC). Patients held a pencil and made movements that did not elicit dystonic symptoms during rTMS. We hypothesized that an active but non-dystonic motor state would increase beneficial effects of rTMS. Five additional patients received sham-rTMS protocol. The area under curve (AUC) of the motor evoked potentials and the cortical silent period (CSP) were measured to assess changes in corticospinal excitability and intracortical inhibition, respectively. Behavioral measures included pen force and velocity during handwriting and subjective report.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dystonia, Focal, Task-specific
Intervention  ICMJE
  • Device: rTMS
    rTMS
    Other Name: Magstim Rapid 2, Magstim Co, Whitland Dyfed, UK
  • Device: Sham rTMS
    Sham rTMS
    Other Name: Placebo Magstim Rapid 2, Magstim Co, Whitland Dyfed, UK
Study Arms  ICMJE
  • 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.
    Intervention: Device: rTMS
  • 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.
    Intervention: Device: Sham rTMS
Publications * Kimberley TJ, Borich MR, Arora S, Siebner HR. Multiple sessions of low-frequency repetitive transcranial magnetic stimulation in focal hand dystonia: clinical and physiological effects. Restor Neurol Neurosci. 2013;31(5):533-42. doi: 10.3233/RNN-120259.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 2, 2015)
17
Original Actual Enrollment  ICMJE
 (submitted: June 19, 2013)
18
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Task specific Focal Hand Dystonia

Exclusion Criteria:

  • any neurologic condition other than FHD
  • medication for dystonia
  • botulinum toxin within the past three months
  • seizure history
  • pregnancy
  • implanted medical devices
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01884064
Other Study ID Numbers  ICMJE 0608M91226
M01RR000400 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Minnesota - Clinical and Translational Science Institute
Study Sponsor  ICMJE University of Minnesota - Clinical and Translational Science Institute
Collaborators  ICMJE
  • Dystonia Medical Research Foundation
  • National Institutes of Health (NIH)
  • National Center for Research Resources (NCRR)
Investigators  ICMJE
Principal Investigator: Teresa J Kimberley, PhD, PT University of Minnesota - Clinical and Translational Science Institute
PRS Account University of Minnesota - Clinical and Translational Science Institute
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP