Sensory-driven Motor Recovery in Poorly Recovered Subacute Stroke Patients

NCT03124186 | Completed

• 1 other identifier: 5R01HD056002
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

Brief Summary

This research project addresses a scientifically important question that cannot be answered by other means. The use of peripheral nerve stimulation has the potential to enhance recovery in subacute stroke patients with poor functional recovery. The primary objective of this proposal is to demonstrate that peripheral nerve stimulation combined with intensive motor training has the ability to further improve hand motor function when compared to intensive training alone or nerve stimulation alone. The results from this study have the potential to develop new strategies in neurorehabilitation.

Conditions

Stroke; Cerebrovascular Accident

Keywords

motor recovery; neuroplasticity; subacute; human; sensory; nerve stimulation

Outcome Measures

Primary Outcomes (1)

• Change in Fugl Meyer Assessment

  The upper extremity FMA is a quantitative measure of motor recovery, sensation, coordination, and speed.

  Score change after 18 days of intervention compared to baseline; Score change after 1- and 4-month after the intervention compared to baseline

Secondary Outcomes (3)

• Change in Action Arm Research Test (ARAT)

  Score change after 18 days of intervention compared to baseline; Score change after 1- and 4-month after the intervention compared to baseline

• Change in Wolf Motor Function Test (WMFT)

  Score change after 18 days of intervention compared to baseline; Score change after 1- and 4-month after the intervention compared to baseline

• Change in Stroke Impact Scale (SIS)

  Score change after 18 days of intervention compared to baseline; Score change after 1- and 4-month after the intervention compared to baseline

Study Arms (2)

Active stimulation with motor training

EXPERIMENTAL

2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.

Device: S88 Dual Output Stimulator by Grass Technologies

Sham stimulation with motor training

ACTIVE COMPARATOR

2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.

Device: S88 Dual Output Stimulator by Grass Technologies

Interventions

S88 Dual Output Stimulator by Grass Technologies DEVICE

Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy

Active stimulation with motor training; Sham stimulation with motor training

Eligibility Criteria

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

You may qualify if:

• Having sustained a single ischemic or hemorrhagic stroke during the 3- to 12-month period preceding enrollment
• Single stroke
• Inability at the time of screening to demonstrate active extension of the affected metacarpophalangeal and interphalangeal joints at least 10°; and the wrist, 20° (ie, level of impairment that would preclude participation in constraint-induced therapy)
• Score of 47 or lower on the modified 30-item Fugl-Meyer Assessment of UE motor function
• Participants NOT able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°.

You may not qualify if:

• History of carpal tunnel syndrome and conditions that commonly cause peripheral neuropathy, including diabetes, uremia, or associated nutritional deficiencies
• History of head injury with loss of consciousness, severe alcohol or drug abuse, psychiatric illness
• Within 3 months of recruitment, use of drugs known to exert detrimental effects on motor recovery
• Cognitive deficit severe enough to preclude informed consent
• Positive pregnancy test or being of childbearing age and not using appropriate contraception
• Participants with history of untreated depression.

Sponsors & Collaborators

• Lumy Sawaki: lead

Related Publications (1)

• Carrico C, Westgate PM, Salmon Powell E, Chelette KC, Nichols L, Pettigrew LC, Sawaki L. Nerve Stimulation Enhances Task-Oriented Training for Moderate-to-Severe Hemiparesis 3-12 Months After Stroke: A Randomized Trial. Am J Phys Med Rehabil. 2018 Nov;97(11):808-815. doi: 10.1097/PHM.0000000000000971.

  PMID: 29794530 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 21, 2017
• Study Start: April 1, 2008
• Primary Completion: June 30, 2013
• Study Completion: June 30, 2013
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share