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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02268461
Recruitment Status : Completed
First Posted : October 20, 2014
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

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
Spasticity Device: repetitive Transcranial Magnetic Stimulation (rTMS) Device: Sham repetitive Transcranial Magnetic Stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : December 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2016

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.




Primary Outcome Measures :
  1. 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.

  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) [ 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.

  3. 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) ]
  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


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) [ 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02268461


Locations
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United States, Minnesota
University of Minnesota, Clinical and Translational Science Institute
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
University of Minnesota
Investigators
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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:
Mathiowetz V, Federman S, Wiemer, D. Box and Block Test of Manual Dexterity: Norms for 6-19 Year Olds. CJOT. 1985b; 52(5): 241-245.
Braddom, Randall L., Ralph M. Buschbacher. Ch 30 Spasticity Management. Physical Medicine & Rehabilitation. Saunders Elsevier 2007; 641-55.

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02268461    
Other Study ID Numbers: rTMS-SP-2014
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: June 2017
Keywords provided by University of Minnesota:
Post-Stroke Spasticity
Additional relevant MeSH terms:
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Muscle Spasticity
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations