Repetitive Transcranial Magnetic Stimulation for the Treatment of Focal Hand Dystonia

NCT ID: NCT01884064

Last Updated: 2016-06-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-07-31

Brief Summary

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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

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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.

Conditions

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Dystonia, Focal, Task-specific

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

rTMS

Intervention Type DEVICE

rTMS

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.

Group Type PLACEBO_COMPARATOR

Sham rTMS

Intervention Type DEVICE

Sham rTMS

Interventions

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rTMS

rTMS

Intervention Type DEVICE

Sham rTMS

Sham rTMS

Intervention Type DEVICE

Other Intervention Names

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Magstim Rapid 2, Magstim Co, Whitland Dyfed, UK Placebo Magstim Rapid 2, Magstim Co, Whitland Dyfed, UK

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dystonia Medical Research Foundation

OTHER

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teresa J Kimberley, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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Program in Physical Therapy, University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 23340117 (View on PubMed)

Other Identifiers

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M01RR000400

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0608M91226

Identifier Type: -

Identifier Source: org_study_id

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