Trial record 7 of 20 for:    "task-specific focal dystonia" OR "embouchure dystonia" OR "focal hand dystonia" OR "musician's dystonia" OR "task-specific dystonia"

Repetitive Transcranial Magnetic Stimulation for the Treatment of Focal Hand Dystonia

This study has been completed.
Sponsor:
Collaborator:
Dystonia Medical Research Foundation
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01884064
First received: June 20, 2012
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

Preliminary results demonstrated no significant changes in cortical excitability or handwriting performance following 5 days of rTMS in focal hand dystonia. However, the majority of subjects reported symptom improvement. Previous research using a similar protocol has shown significant changes in cortical excitability and handwriting performance lasting at least 10-days following treatment. Data collection and analysis is currently in progress. Additionally, Impaired inhibition as measured by CSP may be present in people with oromandibular dystonia, which is a similar finding to other focal dystonias. Inhibitory rTMS may be effective in reducing excitability that may improve clinical symptoms of this disorder.


Condition Intervention Phase
Dystonia, Focal, Task-specific
Device: rTMS
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation for the Treatment of Focal Hand Dystonia

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Cortical silence period


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 18
Study Start Date: July 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: rTMS
rTMS
Other Name: Magstim Rapid 2, Magstim Co, Whitland Dyfed, UK

Detailed Description:

This study investigated the short- and long-term effects of repeated administrations of repetitive-transcranial magnetic stimulation (rTMS) on cortical excitability and handwriting performance. Six subjects with focal hand dystonia (FHD) and nine healthy controls were studied. All subjects with FHD received rTMS (1Hz) to the premotor cortex (PMC) for five consecutive days; of those, three subjects received five days of sham rTMS completed ten days prior to real treatment. Healthy subjects received one real rTMS session. Cortical silent period (CSP) and measures of handwriting performance were compared before and after treatment and at ten-day post-treatment follow-up. At baseline, significant differences in CSP and pen pressure were observed between subjects with FHD and healthy controls. Differences in CSP and pen velocity between subjects in real and sham rTMS groups were observed across treatment sessions and maintained at follow-up. After five days of rTMS to PMC, reduced cortical excitability and improved handwriting performance were observed and maintained at least ten days following treatment in subjects with FHD. These preliminary results support further investigation of the therapeutic potential of rTMS in FHD. We have modified the current treatment parameters to increase the treatment time to build upon these initial findings

  Eligibility

Ages Eligible for Study:   41 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01884064

Locations
United States, Minnesota
Program in Physical Therapy, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Dystonia Medical Research Foundation
Investigators
Principal Investigator: Teresa J Kimberley, PhD, PT University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01884064     History of Changes
Other Study ID Numbers: 0608M91226
Study First Received: June 20, 2012
Last Updated: June 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
focal hand dystonia
rehabilitation
rTMS
writer's cramp
clinical

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases

ClinicalTrials.gov processed this record on August 18, 2014