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

Sponsor
University of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT02268461
Collaborator
(none)
4
Enrollment
1
Location
2
Arms
24
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: repetitive Transcranial Magnetic Stimulation (rTMS)
  • Device: Sham repetitive Transcranial Magnetic Stimulation
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment of Post-Stroke Spasticity
Study Start Date :
Dec 1, 2014
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Change in Baseline Ashworth Scale score from Day 1 (Pre-treatment) to Day 5 (Post-treatment) [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.

    2. 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) [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.

    3. Change in Baseline finger and wrist functional tracking movement from Day 1 (Pre-treatment) to Day 5 (Post-treatment) [Outcome will be assessed on Day 1 (Pre-treatment) and Day 5 (Post-treatment),(Treatment with rTMS will occur on Days 2-4)]

    4. Change in Baseline Corticospinal Excitability Measures from Day 1 (Pre-treatment) to Day 5 (Post-treatment) [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

    Secondary Outcome Measures

    1. Change in performance on the Box and Block Test from Baseline on Day 1 (Pre-treatment) to Day 5 (Post-treatment) [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.

    2. Change in Baseline performance on the Stroke Impact Scale from Day 1 (Pre-treatment) to Day 5 (Post-treatment) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Minnesota, Clinical and Translational Science Institute Minneapolis Minnesota United States 55414

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT02268461
    Other Study ID Numbers:
    • rTMS-SP-2014
    First Posted:
    Oct 20, 2014
    Last Update Posted:
    Apr 12, 2019
    Last Verified:
    Jun 1, 2017
    Keywords provided by University of Minnesota
    Post-Stroke Spasticity
    Additional relevant MeSH terms:
    Muscle Spasticity

    Study Results

    No Results Posted as of Apr 12, 2019