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Repetitive Transcranial Magnetic Stimulation for the Treatment of Focal Hand Dystonia

Primary Purpose

Dystonia, Focal, Task-specific

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
rTMS
Sham rTMS
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dystonia, Focal, Task-specific focused on measuring focal hand dystonia, rehabilitation, rTMS, writer's cramp, clinical

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Program in Physical Therapy, University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

inhibitory rTMS

Sham rTMS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Cortical Silent Period
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.

Secondary Outcome Measures

Full Information

First Posted
June 20, 2012
Last Updated
May 13, 2016
Sponsor
University of Minnesota
Collaborators
Dystonia Medical Research Foundation, National Institutes of Health (NIH), National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT01884064
Brief Title
Repetitive Transcranial Magnetic Stimulation for the Treatment of Focal Hand Dystonia
Official Title
Multiple Sessions of Low-frequency Repetitive Transcranial Magnetic Stimulation in Focal Hand Dystonia: Clinical and Physiological Effects
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
Dystonia Medical Research Foundation, National Institutes of Health (NIH), National Center for Research Resources (NCRR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dystonia, Focal, Task-specific
Keywords
focal hand dystonia, rehabilitation, rTMS, writer's cramp, clinical

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
inhibitory rTMS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham rTMS
Arm Type
Placebo Comparator
Arm Description
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 Type
Device
Intervention Name(s)
rTMS
Other Intervention Name(s)
Magstim Rapid 2, Magstim Co, Whitland Dyfed, UK
Intervention Description
rTMS
Intervention Type
Device
Intervention Name(s)
Sham rTMS
Other Intervention Name(s)
Placebo Magstim Rapid 2, Magstim Co, Whitland Dyfed, UK
Intervention Description
Sham rTMS
Primary Outcome Measure Information:
Title
Cortical Silent Period
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa J Kimberley, PhD, PT
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Program in Physical Therapy, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23340117
Citation
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.
Results Reference
result

Learn more about this trial

Repetitive Transcranial Magnetic Stimulation for the Treatment of Focal Hand Dystonia

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