Peripheral Stimulation Neural Response

Stroke Clinical Trial

Official title:

Effects of Somatosensory Electrical Simulation On Motor Function and Cortical Oscillations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03176550
• Other study ID #: 13-123462
• Status: Completed
• Phase: N/A
• Start date: August 1, 2014
• Est. completion date: April 30, 2015

Study information

• Verified date: March 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 30, 2015
• Est. primary completion date: April 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Transcutaneous electrical nerve stimulation
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Action Research Arm Test (ARAT)		pre- and immediately post-stimulation
Primary	Change in Finger Fractionation		pre- and immediately post-stimulation
Secondary	Change in Modified Ashworth Scale (MAS)		pre- and immediately post-stimulation
Secondary	Resting State EEG		pre- and immediately post-stimulation