Peripheral Stimulation Neural Response

Effects of Somatosensory Electrical Simulation On Motor Function and Cortical Oscillations

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Transcutaneous electrical nerve stimulation

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Action Research Arm Test (ARAT)	pre- and immediately post-stimulation
Change in Finger Fractionation	pre- and immediately post-stimulation

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Modified Ashworth Scale (MAS)	pre- and immediately post-stimulation
Resting State EEG	pre- and immediately post-stimulation

Collaborators and Investigators

• Sponsor: University of California, San Francisco

Publications and helpful links

General Publications

• Tu-Chan AP, Natraj N, Godlove J, Abrams G, Ganguly K. Effects of somatosensory electrical stimulation on motor function and cortical oscillations. J Neuroeng Rehabil. 2017 Nov 13;14(1):113. doi: 10.1186/s12984-017-0323-1.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): April 30, 2015
• Study Completion (Actual): April 30, 2015

Study Registration Dates

• First Submitted: May 24, 2017
• First Submitted That Met QC Criteria: May 31, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 13-123462

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No