Associative Peripheral Stimulation for Reduction of Motor Impairment During Acute Period of Stroke Recovery

NCT06575140 | Recruiting FDA Device

• 1 other identifier: APS-PILOT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

Associative Peripheral Stimulation (APS) is a non-invasive therapy intended for stroke rehabilitation involving transcutaneous electrical muscle stimulation paired with voluntary movement. This pilot study investigates whether APS applied during the acute phase of stroke recovery may reduce impairment and improve function in the affected upper extremity.

Conditions

Stroke; Stroke, Acute; Stroke, Ischemic; Stroke, Hemorrhagic; Hemiparesis; Hemiparesis;Poststroke/CVA; Weakness of Extremities as Sequela of Stroke; Stroke Sequelae; Upper Extremity Paresis

Keywords

Stroke Rehabilitation; Associative Peripheral Stimulation

Outcome Measures

Primary Outcomes (2)

• Maximum Average of Range of Motion (ROM)

  Measure of distal extensor function (wrist and fingers). Unit of measurement: degrees (°). Higher scores indicate better outcomes.

  5 weeks

• Fugl-Meyer Assessment Upper-Extremity (FMA-UE)

  Measure of motor recovery in stroke patients with hemiparesis. Scoring range: 0 to 66. Higher scores indicate better outcomes.

  5 weeks

Secondary Outcomes (4)

• Maximum Average of Range of Motion (ROM)

  3 months

• Fugl-Meyer Assessment Upper-Extremity (FMA-UE)

  3 months

• Action Research Arm Test (ARAT)

  5 weeks

• Action Research Arm Test (ARAT)

  3 months

Study Arms (2)

Group A

EXPERIMENTAL

Treatment

Device: Associative Peripheral Stimulation (APS) 1.0

Group B

ACTIVE COMPARATOR

Control

Device: Peripheral Neuromuscular Stimulation

Interventions

Associative Peripheral Stimulation (APS) 1.0 DEVICE

Associative peripheral stimulation paired with rehabilitative exercises.

Group A

Peripheral Neuromuscular Stimulation DEVICE

Random peripheral stimulation paired with rehabilitative exercises.

Group B

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed ischemic or hemorrhagic stroke no earlier than 7 days prior to enrollment;
• Presentation of hemiparesis or paralysis of the upper extremity due to stroke;
• Ability to comprehend and follow study instructions;
• Ability to initiate finger extension (≥3°) at least three times per minute;
• Fugl-Meyer Assessment (Upper Extremity) score of \<47.

You may not qualify if:

• Contraindications, intolerance, or high sensitivity to the experimental protocol;
• History of upper-extremity disability prior to the index stroke;
• Neurological conditions (other than stroke) affecting motor function;
• Treatment of spasticity/increased tone in the affected upper extremity (e.g., with Botox injection);
• Lack of access to a safe and suitable place of discharge for experimental sessions and follow-up visits.

Sponsors & Collaborators

• Ahmed A. Rahim: lead

Study Sites (3)

General Hospital of Mexico

Mexico City, Mexico

RECRUITING

La Raza National Medical Center

Mexico City, Mexico

RECRUITING

National Institute of Neurology & Neurosurgery

Mexico City, Mexico

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel San Juan Orta, MD

  National Institute of Neurology & Neurosurgery

  STUDY DIRECTOR

Central Study Contacts

Ahmed A Rahim, MTM

CONTACT

+1 (916) 825-8792; ahmed.rahim@alumni.ucsf.edu

Study Design

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

Study Record Dates

• First Submitted: March 24, 2019
• First Posted: August 28, 2024
• Study Start: December 18, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (3)