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Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment of Post-Stroke Spasticity

NCT02268461 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-01-27

Study results available
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Summary

Spasticity is a common complication of stroke affecting quality of life. Spasticity involves exaggerated stretch reflexes that create stiffness in muscles with associated loss of motion and functional control. Traditional treatments involve range of motion, medications, and sometimes surgery. Each of these has its own limitations, which has invited exploration of alternative modes of treatment. One such treatment with the potential to benefit spasticity is repetitive Transcranial Magnetic Stimulation (rTMS).

The purpose of this study is to determine whether patients with upper limb spasticity as a consequence of a chronic stroke can benefit from stimulation of the non-affected hemisphere of the brain with low-frequency (inhibitory) repetitive Transcranial Magnetic Stimulation (rTMS), potentially leading to a reduction of spasticity and clinical improvement in upper limb function.

Conditions

  • Spasticity

Interventions

DEVICE

repetitive Transcranial Magnetic Stimulation (rTMS)

The treatment arm will consist of 3 daily treatment sessions. One treatment session in this study with real rTMS will consist of 600 pulses of 1Hertz rTMS at an intensity of 90% of resting motor threshold (duration 10 minutes) applied to the primary motor area of the contralesional hemisphere.

DEVICE

Sham repetitive Transcranial Magnetic Stimulation

Sham rTMS utilizes a coil that produces identical noise and tactile sensation to the real coil, but does not emit a magnetic field (0% intensity). Duration and frequency of auditory and tactile stimulation will be identical to the real intervention.

Sponsors & Collaborators

Principal Investigators

  • Matthew J Timp, DO · University of Minnesota, Physical Medicine and Rehabilitation

  • James R Carey, PhD, PT · University of Minnesota, Program in Physical Therapy

  • Florence S John, MD, MPH · University of Minnesota, Physical Medicine and Rehabilitation

  • Kate Frost, MS · University of Minnesota, Program in Physical Therapy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-10-31
Completion
2016-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02268461 on ClinicalTrials.gov