Effects of Home-based Neurostimulation Associated With Motor Training in Chronic Stroke Patients

Objective: To investigate effects of home-based somatosensory stimulation associated with motor training on improvement in performance of the paretic upper extremity in patients in the chronic phase after stroke.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Relief band (Somatosensory stimulation); Device: Placebo stimulation

Detailed Description

Design: Double-blind, randomized, controlled clinical trial. Setting: Home-based rehabilitation. Subjects: Patients in the chronic phase (> 6 months) after stroke. Interventions: Patients will be randomized to an active and a control group. In both groups, treatments will be performed at home, daily, over four weeks. Patients in the active group will be instructed to use a device that provides somatosensory stimulation in the form of electrical stimulation of the median nerve for two hours. Patients in the control group will also be instructed to use the device for two hours, and sham stimulation will be administered. In both groups, patients will be instructed to train activities with the paretic hand immediately after nerve stimulation.

Main measures: The primary outcome will be improvement in performance of the paretic hand evaluated by the Jebsen-Taylor test at end of treatment and four months after end of treatment, compared to baseline. Secondary outcomes were: 1) Compliance with the interventions, assessed through a daily written log, and oral reports of the patients; 2) safety profile of the interventions.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 55
      • University of São Paulo/General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age 18-80 years;
• single ischemic or hemorrhagic stroke in a cerebral hemisphere, documented by computed tomography (CT) or magnetic resonance imaging (MRI);
• stroke onset at least six months before;
• hand paresis with preserved ability to perform all tasks of the Jebsen-Taylor Test (JTT).

Exclusion Criteria:

• previous strokes;
• epilepsy and other neurological conditions;
• proprioceptive or tactile anesthesia;
• shoulder or hand pain;
• severe joint deformity;
• severe chronic disease;
• inability to give provide informed consent due to severe aphasia or cognitive impairment;
• left handedness before the stroke.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Somatosensory stimulation; Active group	Device: Relief band (Somatosensory stimulation); Electrical median nerve stimulation; Other Names: Relief band
Placebo Comparator: Control group; Placebo stimulation	Device: Placebo stimulation; Placebo stimulation; Other Names: no stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the improvement in upper extremity performance assessed using Jebsen-Taylor test	Treatment lasted four weeks. Measures were performed before the treatment, immediately after the treatment and four months after the end of the treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Compliance with the interventions, assessed through a daily written log, and oral reports of the patients	immediately after the treatment
Adverse events	at end of treatment

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo; Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Investigators: Principal Investigator: Adriana Conforto, MD PhD, Hospital das Clínicas/FMUSP

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: December 11, 2009
• First Submitted That Met QC Criteria: December 16, 2009
• First Posted (Estimate): December 17, 2009

Study Record Updates

• Last Update Posted (Estimate): December 17, 2009
• Last Update Submitted That Met QC Criteria: December 16, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 1309-06; 477916/06-6 (Other Grant/Funding Number: CNPq)