- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01884064
Repetitive Transcranial Magnetic Stimulation for the Treatment of Focal Hand Dystonia
May 13, 2016 updated by: University of Minnesota
Multiple Sessions of Low-frequency Repetitive Transcranial Magnetic Stimulation in Focal Hand Dystonia: Clinical and Physiological Effects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
17
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Program in Physical Therapy, University of Minnesota
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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rTMS
Other Names:
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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.
|
Sham rTMS
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline and Day 5
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Teresa J Kimberley, PhD, PT, University of Minnesota
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
June 20, 2012
First Submitted That Met QC Criteria
June 19, 2013
First Posted (Estimate)
June 21, 2013
Study Record Updates
Last Update Posted (Estimate)
June 17, 2016
Last Update Submitted That Met QC Criteria
May 13, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0608M91226
- M01RR000400 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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