Overview

This trial is active, not recruiting.

Condition spasticity
Treatments repetitive transcranial magnetic stimulation (rtms), sham repetitive transcranial magnetic stimulation
Sponsor University of Minnesota - Clinical and Translational Science Institute
Start date December 2014
End date October 2016
Trial size 6 participants
Trial identifier NCT02268461, rTMS-SP-2014

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
repetitive Transcranial Magnetic Stimulation (rTMS)
repetitive transcranial magnetic stimulation (rtms) Magstim 200^2 Magnetic Stimulator (MODEL 3010-00)
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.
(Sham Comparator)
Sham repetitive Transcranial Magnetic Stimulation (Sham rTMS)
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 Outcomes

Measure
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)
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)
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)
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)

Secondary Outcomes

Measure
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)
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)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment of Post-Stroke Spasticity
Principal investigator Matthew J Timp, DO
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Minnesota - Clinical and Translational Science Institute.