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Repetitive Transcranial Magnetic Stimulation for the Treatment of Focal Hand Dystonia

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01884064
Enrollment
17
Registered
2013-06-21
Start date
2008-07-31
Completion date
2010-07-31
Last updated
2016-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dystonia, Focal, Task-specific

Keywords

focal hand dystonia, rehabilitation, rTMS, writer's cramp, clinical

Brief 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.

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.

Interventions

DEVICErTMS

rTMS

DEVICESham rTMS

Sham rTMS

Sponsors

Dystonia Medical Research Foundation
CollaboratorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
National Center for Research Resources (NCRR)
CollaboratorNIH
University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cortical Silent PeriodBaseline and Day 5Subjects 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. rTMS: rTMS
12
Sham rTMS
Sham 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. Sham rTMS: Sham rTMS
5
Total17

Baseline characteristics

CharacteristicrTMSSham rTMSTotal
Age, Continuous46.5 years
STANDARD_DEVIATION 12.4
46.6 years
STANDARD_DEVIATION 14.8
46.5 years
STANDARD_DEVIATION 12.4
Sex: Female, Male
Female
5 Participants2 Participants7 Participants
Sex: Female, Male
Male
7 Participants3 Participants10 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
3 / 120 / 5
serious
Total, serious adverse events
0 / 120 / 5

Outcome results

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.

Time frame: Baseline and Day 5

ArmMeasureValue (MEAN)Dispersion
rTMSCortical Silent Period9 millisecondsStandard Deviation 6.9
Sham rTMSCortical Silent Period1.61 millisecondsStandard Deviation 15.7

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026