Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment of Post-Stroke Spasticity
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/28/2017 |
| Start Date: | December 2014 |
| End Date: | December 2016 |
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.
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.
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.
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.
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
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