Spinal Cord Stimulation for Restoration of Arm and Hand Function in People With Subcortical Stroke

Not Applicable

Active, not recruiting

• Conditions: Stroke; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases

• Registration Number: NCT04512690
• Lead Sponsor: Lee Fisher, PhD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-7-24
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Single, ischemic or hemorrhagic stroke resulting in upper extremity hemiparesis more<br> than 6 months prior to the time of enrollment. (Prior strokes that did not cause<br> upper extremity motor deficits are not exclusionary.)<br><br> 2. Participants must be between the ages of 21 and 70 years old.<br><br> 3. Scores higher than 7 and lower than 50 on the Fugl-Meyer scale<br><br>Exclusion Criteria:<br><br> 1. Serious disease or disorder (ex. neurological condition other than stroke, cancer,<br> severe cardiac or respiratory disease, renal failure, etc.) or cognitive impairments<br> that could affect the ability to participate in study activities.<br><br> 2. Pregnancy or breast feeding.<br><br> 3. Receiving anticoagulant, anti-spasticity or anti-epileptic medications throughout<br> the duration of the study.<br><br> 4. Presence of any implanted medical devices.<br><br> 5. Severe claustrophobia.<br><br> 6. Presence of joint contractures deemed by study clinician/investigator to be too<br> severe to participate in study activities<br><br> 7. Results from the Brief Symptoms Inventory (BSI-18) and additional discussions with<br> the Principal Investigator and a study physician that deem participant inappropriate<br> for the study.<br><br> 8. Evaluation to sign consent form score <12.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse Events;Discomfort and Pain

Secondary Outcome Measures

Name	Time	Method
Motor Impairment;Dexterity / Function: Action Research Arm Test;Single Joint Force;Joint Velocity;Movement Smoothness;Time to Target;Sensory motor integration: success-rate;Sensory motor integration: displacement error;Spasticity;Sensorimotor Network Function;Sensorimotor Network Structure Integrity;Cortico-spinal Tract Integrity;Spinal Circuit Excitability;Motoneuron Firing Rates