Noninvasive Spinal Stimulation in Stroke



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:10/24/2018
Start Date:August 17, 2018
End Date:December 31, 2020
Contact:Kelly McKenzie, DPT
Email:kaskins@sralab.org
Phone:312-238-7111

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Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke

This is a randomized control trial that will evaluate the effectiveness of transcutaneous
(non-invasive) spinal cord stimulation on gait and balance function for individuals with
hemiplegia due to stroke.

OBJECTIVES:

- To determine whether transcutaneous spinal cord stimulation combined with ambulation
training modulates corticospinal locomotor networks in individuals with chronic
hemiplegic stroke

- To determine whether transcutaneous spinal stimulation combined with ambulation training
improves locomotor function in individuals with chronic hemiplegic stroke

- To determine whether transcutaneous spinal stimulation combined with ambulation training
improves symmetry of gait in individuals with chronic hemiplegic stroke

- To determine whether transcutaneous spinal stimulation combined with ambulation training
improves standing posture and balance in individuals with chronic hemiplegic stroke

- To determine whether ambulation efficiency (improved cardiovascular conditioning)
improves with transcutaneousnon-invasive spinal stimulation and locomotor training in
individuals with chronic hemiplegic stroke

Inclusion Criteria:

- Participants are 18 years of age or older

- Participants are at least 4 weeks post stroke

- Participants with hemiplegia secondary to a single stroke

- Functional Ambulation Category of 2 or greater - Patient needs continuous or
intermittent support of one person to help with balance and coordination.

- Participants are able to provide informed consent

- Participants are not currently receiving regular physical therapy services

Exclusion Criteria:

- Individuals less than18 years of age

- Individuals less than 4 weeks post stroke

- Individuals with ataxia

- Individuals with multiple stroke history

- Currently taking medication for spasticity management or depression

- Modified Ashworth score of 3 or greater in lower extremity

- Pregnancy or nursing

- Pacemaker or anti-spasticity implantable pumps

- Active pressure sores

- Unhealed bone fractures

- Peripheral neuropathies

- Painful musculoskeletal dysfunction due to active injuries or infections

- Severe contractures in the lower extremities

- Cardiopulmonary disease

- Active urinary tract infection

- Clinically significant depression, psychiatric disorders, or ongoing drug abuse

- Metal implants in their spine

TMS Specific Exclusion Criteria:

- Medicated with agents known to increase (e.g., amphetamines) or decrease motor system
excitability (e.g., lorazepam)

- Implanted cardiac pacemaker

- Metal implants in the head or face

- Suffers unexplained, recurring headaches

- Had a seizure at any time in the past, or has epilepsy

- Skull abnormalities or fractures

- Suffered a concussion within the last 6 month

- Cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled
hypertension or diabetes, chronic emphysema)

- Pregnant
We found this trial at
1
site
355 East Erie Street
Chicago, Illinois 60611
Principal Investigator: Arun Jayaraman, PT,PhD
Phone: 312-238-2091
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mi
from
Chicago, IL
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