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

August 30, 2022 updated by: University of Minnesota

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this pilot study is to evaluate the efficacy of rTMS versus placebo for spasticity reduction in a cross-over design in 6 people with stroke.

Our research question is: In patients with upper extremity spasticity as a consequence of chronic stroke, does stimulation of the contralesional motor cortex with low-frequency (inhibitory) rTMS lead to reduction of spasticity and thereby clinical improvement in upper extremity function? Our rationale is that the pathophysiology of post-stroke spasticity is primarily driven by ensuant cortical derangement, and further, that this derangement can be mitigated to a clinically meaningful extent by proper utilization of rTMS directed at these foci. Optimized rTMS treatment protocols may even achieve efficacy that surpasses current mainstays of spasticity management.

Patients will be randomly assigned to receive either rTMS or placebo during their first treatment arm and then cross-over to receive the opposite treatment at the second treatment arm. A washout period of one month will occur between treatment arms. Each treatment arm will consist of 3 daily treatment sessions. Participants will present on a Monday for the pre-test assessment, Tuesday-Thursday for the treatment sessions and Friday for the post-test assessment. One treatment session 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. Sham rTMS intensity will be 0% but with a similar sound and scalp sensation. Assessments will be made at each session, and will be conducted at pre-test, post-test, and one-month follow-up. The one month follow-up test will serve as the pretest for the next treatment arm. That is, after follow-up, patients will cross-over to receive the opposite treatment in the same format. Safety has already been demonstrated for our protocol. Data will be analyzed with methods appropriate to a single-subject crossover design (visual analysis, confidence intervals and 2-Standard Deviation bandwidth).

The primary outcome that we will measure is reduction of spasticity at the fingers and wrist. A secondary outcome of interest is functional improvement of the spastic upper limb.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

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

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • University of Minnesota, Clinical and Translational Science Institute

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. first-time stroke
  2. stroke at least six months prior to onset of study with chronic sequela of spasticity
  3. stroke location- either cortical or subcortical
  4. stroke type- either hemorrhagic or ischemic
  5. stroke hemisphere- either left or right, dominant or non- dominant hemisphere
  6. 18 years of age or older
  7. gender- either male or female
  8. ability to follow three-step directions
  9. demonstration of 10 degrees of active extension at the metacarpophalangeal joint and wrist of the paretic upper extremity
  10. demonstration of consistent resting motor evoked potential from ipsilesional and contralesional hemispheres
  11. sufficient ambulation or wheelchair mobility to allow subject to present to treatment and testing areas with minimum assist

Exclusion Criteria:

  1. history of seizure within the past two years
  2. inability to follow three-step directions
  3. anosognosia
  4. moderate to severe receptive aphasia
  5. inability to give informed consent
  6. premorbid spasticity or neurologic impairment prior to stroke
  7. co-morbidities impairing upper extremity function such as fracture or deformity
  8. indwelling metal or medical devices incompatible with TMS
  9. pregnancy
  10. bi-hemispheric or multifocal stroke
  11. dementia
  12. neurolytic injection within the 3 months prior to onset of study or planned neurolytic injection during study period
  13. planned vacation or travel during study period

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: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: rTMS
repetitive Transcranial Magnetic Stimulation (rTMS)
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.
Other Names:
  • Magstim 200^2 Magnetic Stimulator (MODEL 3010-00)
  • Magstim Rapid^2 Magnetic Stimulator (MODE 3004-000)
Sham Comparator: Sham rTMS
Sham repetitive Transcranial Magnetic Stimulation (Sham rTMS)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Baseline Ashworth Scale score from Day 1 (Pre-treatment) to Day 5 (Post-treatment)
Time Frame: Outcome will be assessed on Day 1 (Pre-treatment) and Day 5 (Post-treatment),(Treatment with rTMS will occur on Days 2-4)
The Ashworth scale will test resistance to passive movement around a joint with varying degrees of velocity, and will be used to assess muscle tone, and thus any improvement in spasticity.
Outcome will be assessed on Day 1 (Pre-treatment) and Day 5 (Post-treatment),(Treatment with rTMS will occur on Days 2-4)
Change in Baseline Active Range of Motion of the index finger metacarpophalangeal joint and wrist joint by electrogoniometer from Day 1 (Pre-treatment) to Day 5 (Post-treatment)
Time Frame: Outcome will be assessed on Day 1 (Pre-treatment) and Day 5 (Post-treatment),(Treatment with rTMS will occur on Days 2-4)
Range of motion testing will assess mobility of the joints with the aid of an electrogoniometer to help measure joint angles to assess improvement in impairment and disability of the affected joint.
Outcome will be assessed on Day 1 (Pre-treatment) and Day 5 (Post-treatment),(Treatment with rTMS will occur on Days 2-4)
Change in Baseline finger and wrist functional tracking movement from Day 1 (Pre-treatment) to Day 5 (Post-treatment)
Time Frame: Outcome will be assessed on Day 1 (Pre-treatment) and Day 5 (Post-treatment),(Treatment with rTMS will occur on Days 2-4)
Outcome will be assessed on Day 1 (Pre-treatment) and Day 5 (Post-treatment),(Treatment with rTMS will occur on Days 2-4)
Change in Baseline Corticospinal Excitability Measures from Day 1 (Pre-treatment) to Day 5 (Post-treatment)
Time Frame: Outcome will be assessed on Day 1 (Pre-treatment) and Day 5 (Post-treatment),(Treatment with rTMS will occur on Days 2-4)
Corticospinal excitability measures used will include threshold and motor evoked potential (MEP) amplitude and cortical silent period duration
Outcome will be assessed on Day 1 (Pre-treatment) and Day 5 (Post-treatment),(Treatment with rTMS will occur on Days 2-4)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in performance on the Box and Block Test from Baseline on Day 1 (Pre-treatment) to Day 5 (Post-treatment)
Time Frame: Outcome will be assessed on Day 1 (Pre-treatment) and Day 4 (Post-treatment),(Treatment with rTMS will occur on Days 2-4)
The Box and Block Test will measure unilateral gross manual dexterity to assess for functional improvement.
Outcome will be assessed on Day 1 (Pre-treatment) and Day 4 (Post-treatment),(Treatment with rTMS will occur on Days 2-4)
Change in Baseline performance on the Stroke Impact Scale from Day 1 (Pre-treatment) to Day 5 (Post-treatment)
Time Frame: Outcome will be assessed on Day 1 (Pre-treatment) and Day 5 (Post-treatment),(Treatment with rTMS will occur on Days 2-4)
The Stroke Impact Scale is a 59 item questionnaire that will be utilized to evaluate aspects of stroke recovery and evaluate any improvement in strength, hand function, mobility and other parameters.
Outcome will be assessed on Day 1 (Pre-treatment) and Day 5 (Post-treatment),(Treatment with rTMS will occur on Days 2-4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Matthew J Timp, DO, University of Minnesota, Physical Medicine and Rehabilitation
  • Study Chair: James R Carey, PhD, PT, University of Minnesota, Program in Physical Therapy
  • Study Director: Florence S John, MD, MPH, University of Minnesota, Physical Medicine and Rehabilitation
  • Study Director: Kate Frost, MS, University of Minnesota, Program in Physical Therapy

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.

General Publications

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

December 1, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 9, 2014

First Submitted That Met QC Criteria

October 15, 2014

First Posted (Estimate)

October 20, 2014

Study Record Updates

Last Update Posted (Actual)

September 6, 2022

Last Update Submitted That Met QC Criteria

August 30, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1408M53261

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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