Peripheral Stimulation Neural Response

NCT03176550 | Completed

• 1 other identifier: 13-123462
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• Change in Action Research Arm Test (ARAT)

  pre- and immediately post-stimulation

• Change in Finger Fractionation

  pre- and immediately post-stimulation

Secondary Outcomes (2)

• Change in Modified Ashworth Scale (MAS)

  pre- and immediately post-stimulation

• Resting State EEG

  pre- and immediately post-stimulation

Interventions

Transcutaneous electrical nerve stimulation DEVICE

TENS is performed using a commercially available device (ProStim, Alimed Inc, Dedham, Massachusetts, USA). One pair of 2 x 3.5 inches rectangular electrodes (Vermed ChroniCare TENS Electrodes, Vermed, Buffalo, NY, USA) are placed to simultaneously stimulate both median and ulnar nerves at the wrist, while a second pair of round 2 inch diameter electrodes are used to stimulate the radial nerve on the forearm. Bursts of electrical stimulation at 10 Hz (100 microsecond pulse width duration) are delivered to all nerves simultaneously for 2 hours.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Related Publications (1)

• 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.

  PMID: 29132379 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: June 5, 2017
• Study Start: August 1, 2014
• Primary Completion: April 30, 2015
• Study Completion: April 30, 2015
• Last Updated: May 24, 2023

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share