Peripheral Nerve Stimulation to Improve Upper Extremity Function After Severe Stroke

Stroke Clinical Trial

Official title:

Peripheral Nerve Stimulation to Improve Upper Extremity Function After Severe Stroke

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04576013
• Other study ID #: 44185
• Status: Terminated
• Phase: N/A
• Start date: February 23, 2016
• Est. completion date: February 22, 2021

Study information

• Verified date: February 2021
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Subjects will receive non-invasive stimulation of nerves on their arm and intensive motor training of their arm. The timing of the stimulation in relation to the training will vary by group.

Description:

This study will look at the differences in improvement of hand and arm function when nerve stimulation is applied at different times in relation to motor training. The nerve stimulation, called peripheral nerve stimulation (PNS), is non-invasive and painless. Subjects in the study may receive strong or mild PNS. Subjects will also vary by whether PNS is delivered for 2 hours before the 2 hours of motor training, or during the 2 hours of motor training. Which level of stimulation and its timing will be determined randomly for each subject.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: February 22, 2021
• Est. primary completion date: February 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have severe upper extremity motor deficit after a single stroke
• Stroke onset at least 12 months ago

Exclusion Criteria:

• Addition or change in the dosage of drugs known to exert detrimental effects on motor recovery within 3 months of enrollment
• Untreated depression
• History of multiple strokes
• History of seizure
• History of head injury with loss of consciousness, severe alcohol or drug abuse, or psychiatric illness
• Positive pregnancy test or being of childbearing age and not using appropriate contraception
• Presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure, and surgical clips in or near the brain
• Cardiac or neural pacemakers or implanted medication pumps
• Receptive aphasia

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Peripheral nerve stimulation (PNS)
Non-invasive stimulation is applied to 3 nerves of the arm. The stimulation will be set at a level that is not painful or uncomfortable.

Behavioral:
• Intensive upper extremity motor training

Locations

Country	Name	City	State
United States	University of Kentucky at Cardinal Hill Rehabilitation Hospital	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment	This is a quantitative measure of motor recovery, coordination, and speed.	Baseline, Immediately post-intervention
Secondary	Action Research Arm Test	This test measures changes in the upper extremity and consists of four specific tests to measure grasp, grip, pinch, and gross movement.	Baseline, Immediately post-intervention
Secondary	Stroke Impact Scale	This is a self-report that assesses strength, hand function, activities of daily living, mobility, communication, emotion, memory and thinking, and participation.	Baseline, Immediately post-intervention
Secondary	Cortical motor map volume	This is performed using non-invasive transcranial magnetic stimulation to determine which parts of the brain control a muscle in the arm or hand.	Baseline, Immediately post-intervention