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Completed

NCT Number: NCT01884064

Repetitive Transcranial Magnetic Stimulation for the Treatment of Focal Hand Dystonia

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.

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Key information

Conditions

Dystonia, Focal, Task-specific Central Nervous System Diseases Dystonic Disorders Movement Disorders Nervous System Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Program in Physical Therapy, University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rTMS

Device

rTMS

Other names: Magstim Rapid 2, Magstim Co, Whitland Dyfed, UK

sham rTMS

Device

Sham rTMS

Other names: Placebo Magstim Rapid 2, Magstim Co, Whitland Dyfed, UK

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Dystonia Medical Research Foundation
  • National Center for Research Resources (NCRR)
  • National Institutes of Health (NIH)

Registry information

Official study title

Multiple Sessions of Low-frequency Repetitive Transcranial Magnetic Stimulation in Focal Hand Dystonia: Clinical and Physiological Effects

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 21, 2013
Registry last updated
Jun 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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