Peripheral Stimulation Neural Response

Not Applicable

Completed

• Conditions: Stroke

• Registration Number: NCT03176550
• Lead Sponsor: University of California, San Francisco

Brief Summary

Few patients recover full hand dexterity after an acquired brain injury such as stroke. Repetitive somatosensory electrical stimulation (SES) is a promising method to promote recovery of hand function. However, studies using SES have largely focused on gross motor function; it remains unclear if it can modulate distal hand functions such as finger individuation. The specific goal of this study was to monitor the effects of SES on individuation as well as on cortical oscillations measured using EEG, with the additional goal of identifying neurophysiological biomarkers.

Detailed Description

Participants with a history of acquired brain injury and distal upper limb motor impairments will receive a single two-hour session of SES using transcutaneous electrical nerve stimulation. Pre- and post-intervention assessments consist of the Action Research Arm Test (ARAT), finger fractionation, pinch force, and the modified Ashworth scale (MAS), along with resting-state EEG monitoring. We will assess for any association between SES and changes in motor outcome as measured using the ARAT, MAS and finger fractionation. In addition, EEG power analyses will be performed to determine if there are any differences between SES responders vs. non-responders.

Study Timeline

• Study Start: 2014-08-01
• Primary Completion: 2015-04-30
• Study Completion: 2015-04-30
• Study First Submitted: 2017-05-24
• Study First Submitted QC: 2017-05-31
• Study First Posted: 2017-06-05
• Status Verified: 2020-03
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• between 18-80 years old, with a history of an acquired brain injury resulting in residual hemiparesis or other motor deficits of the arm/hand equal to or more than 6 months prior to enrollment; and capacity to adhere with the schedule of interventions and evaluations determined in the protocol.

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Exclusion Criteria

• Subjects are excluded if they met any of the following criteria: currently pregnant; uncontrolled medical conditions; significant cognitive impairment on the Montreal Cognitive Assessment (MoCA ≤ 23); ≤ 10 degrees of active index finger range of motion; significant hand joint deformity; severe active alcohol or drug abuse; significant depression (PHQ-9 ≥15); baseline spasticity score (MAS) >3 for any joint tested (wrist and metacarpophalangeal joint flexion and extension); apraxia screen of Tulia (AST) <5; absent light touch, proprioception, pinprick and vibration sensation on the modified Nottingham Sensory Assessment; no upper limb strength against gravity; severe aphasia; or had an implanted pacemaker.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Action Research Arm Test (ARAT)	pre- and immediately post-stimulation
Change in Finger Fractionation	pre- and immediately post-stimulation

Secondary Outcome Measures

Name	Time	Method
Resting State EEG	pre- and immediately post-stimulation
Change in Modified Ashworth Scale (MAS)	pre- and immediately post-stimulation