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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01884064
Other study ID # 0608M91226
Secondary ID M01RR000400
Status Completed
Phase Phase 1
First received June 20, 2012
Last updated October 2, 2015
Start date July 2008
Est. completion date July 2010

Study information

Verified date October 2015
Source University of Minnesota - Clinical and Translational Science Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Device:
rTMS
rTMS
Sham rTMS
Sham rTMS

Locations

Country Name City State
United States Program in Physical Therapy, University of Minnesota Minneapolis Minnesota

Sponsors (4)

Lead Sponsor Collaborator
University of Minnesota - Clinical and Translational Science Institute Dystonia Medical Research Foundation, National Center for Research Resources (NCRR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline and Day 5 No