A Novel Approach for Brain Stimulation in Severe Stroke
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 3/13/2019 |
| Start Date: | April 1, 2019 |
| End Date: | September 30, 2021 |
| Contact: | Kyle J. O'Laughlin, MS |
| Email: | olaughk@ccf.org |
| Phone: | 216-445-6728 |
The long-term goal of this project is to develop upper limb rehabilitation interventions that
can be utilized for stroke survivors, specifically survivors with more severe limitations in
use of their affected upper limb.
This study will utilize a novel method of non-invasive brain stimulation in conjunction with
upper limb training given for 15 visits over a period of 5 weeks.
The study will include the following site visits:
- Eligibility Screening and Informed Consent Visit
- An MRI visit
- Two testing visits in which motor function of the upper limb and neurophysiology will be
measured
- Fifteen intervention visits during which patients will receive upper limb training in
conjunction with non-invasive brain stimulation
- Repeat testing of motor function of the upper limb and neurophysiology
- Repeat MRI testing
- A follow-up visit completed 3 months after the completion of interventions
can be utilized for stroke survivors, specifically survivors with more severe limitations in
use of their affected upper limb.
This study will utilize a novel method of non-invasive brain stimulation in conjunction with
upper limb training given for 15 visits over a period of 5 weeks.
The study will include the following site visits:
- Eligibility Screening and Informed Consent Visit
- An MRI visit
- Two testing visits in which motor function of the upper limb and neurophysiology will be
measured
- Fifteen intervention visits during which patients will receive upper limb training in
conjunction with non-invasive brain stimulation
- Repeat testing of motor function of the upper limb and neurophysiology
- Repeat MRI testing
- A follow-up visit completed 3 months after the completion of interventions
In a pilot, randomized controlled study, 24 stroke patients with moderate/severe impairments
will receive non-invasive brain stimulation (repetitive Transcranial Magnetic Stimulation or
rTMS) to one of two targets in the brain in conjunction with upper limb training for 3 days a
week for 5 weeks. The primary outcome will be upper limb motor impairment, and secondary
outcomes will be tests of functional abilities, proximal reaching performance and
patient-reported disability. Associated neural mechanisms will also be studied using
neurophysiological and functional connectivity MRI techniques. Damage to ipsilesional
corticospinal pathways will be indexed with diffusion tensor imaging (DTI).
will receive non-invasive brain stimulation (repetitive Transcranial Magnetic Stimulation or
rTMS) to one of two targets in the brain in conjunction with upper limb training for 3 days a
week for 5 weeks. The primary outcome will be upper limb motor impairment, and secondary
outcomes will be tests of functional abilities, proximal reaching performance and
patient-reported disability. Associated neural mechanisms will also be studied using
neurophysiological and functional connectivity MRI techniques. Damage to ipsilesional
corticospinal pathways will be indexed with diffusion tensor imaging (DTI).
Inclusion Criteria:
- chronic phase (≥6 months) after index stroke
- moderate or severely impaired (UEFM ≤42) with extensive damage to ipsilesional
pathways (MEP-)
- able to perform the reaching-response time task
- medically stable
Exclusion Criteria:
- cortical stroke affecting motor areas (identified using T1-weighted MRI)
- brainstem stroke
- bilateral strokes
- severe cognitive impairment (Mini-Mental State Examination (MMSE) score ≤ 24)
- substantially elevated tone/spasticity in wrist/hand (Modified Ashworth Scale >3)
- severe contracture
- participation in outpatient or Botox therapy within 3 months
- exclusion criteria for TMS and MRI (metal implant in head, H/O seizures, alcohol or
substance abuse, intake of medications contraindicated with TMS, cardiac pacemaker or
programmable implant).
We found this trial at
1
site
Cleveland, Ohio 44195
Principal Investigator: Ela Plow, PhD
Phone: 216-445-6728
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