Status:
TERMINATED
Transcutaneous Spinal and Peripheral Stimulation and Wrist Robotic Therapy for Patients With Spastic Stroke
Lead Sponsor:
Northwell Health
Conditions:
Spasticity as Sequela of Stroke
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to investigate if two courses of five consecutive sessions of noninvasive spinal stimulation paired with peripheral nerve stimulation at the forearm provided by an investi...
Detailed Description
Stroke is the fifth leading cause of death and the leading cause of serious long-term disability in the U.S. Post-stroke impairment often presents as weakness of the upper and lower limbs and spastici...
Eligibility Criteria
Inclusion
- ≥ 18 years of age
- First and only single focal unilateral hemisphere lesion with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior
- Cognitive function sufficient to understand the experiments and follow instructions (per interview with PI or study investigators)
- Fugl-Meyer assessment (minimum score of 12 out of 66 - not completely plegic in the muscles of affected wrist)
- A Modified Ashworth score between 1-3 points for wrist flexors and extensors
- A minimum of 15 degrees wrist passive ROM for wrist flexion and extension from wrist neutral position
- Body fat range of 15-25mm for females/10-20mm for males of adipose tissue at the cervical neck level and a body fat range of 10-40mm for females/5-35mm for males of adipose tissue at the suprailiac crest, as determined by a body fat caliper
Exclusion
- Botox or phenol alcohol treatment of the upper extremity within 3 months of stimulation intervention
- Fixed contracture or complete flaccid paralysis of the affected wrist
- Introduction of any new rehabilitation interventions during study
- Pregnant or plan on becoming pregnant or breastfeeding during the study period as determined by self-report
- Focal brainstem or thalamic infarcts
- Prior surgical treatments for spasticity of the upper limb
- Ongoing use of CNS-active medications for spasticity (enrollment to be determined by PI review)
- History of spinal cord injury or weakness
- Chronic pain, defined by a report of a "5" or greater on the Wong-Baker Pain Scale
- Peripheral neuropathy including insulin dependent diabetes as determined by case history
- Presence of additional potential tsDCS risk factors:
- Damaged skin at the site of stimulation (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed recent scar tissue, broken skin, etc.)
- Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system; Loop recorders will be reviewed on a case by case basis by PI and the treating Cardiologist to make a determination
- Highly conductive metal in any part of the body, including metal injury to the eye (jewelry must be removed during stimulation); this will be reviewed on a case by case basis for PI to make a determination
- Past history of seizures or unexplained spells of loss of consciousness during the previous 36 months
Key Trial Info
Start Date :
September 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04113525
Start Date
September 24 2019
End Date
February 15 2022
Last Update
April 14 2022
Active Locations (1)
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1
The Feinstein Institutes For Medical Research - Northwell Health
Manhasset, New York, United States, 11030