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

This study has been completed.
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01034150
First received: December 11, 2009
Last updated: December 16, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Stroke
Device: Relief band (Somatosensory stimulation)
Device: Placebo stimulation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Home-based Neurostimulation Associated With Motor Training in Chronic Stroke Patients

Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • the improvement in upper extremity performance assessed using Jebsen-Taylor test [ Time Frame: Treatment lasted four weeks. Measures were performed before the treatment, immediately after the treatment and four months after the end of the treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Compliance with the interventions, assessed through a daily written log, and oral reports of the patients [ Time Frame: immediately after the treatment ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: at end of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: December 2007
Study Completion Date: November 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Somatosensory stimulation
Active group
Device: Relief band (Somatosensory stimulation)
Electrical median nerve stimulation
Other Name: Relief band
Placebo Comparator: Control group
Placebo stimulation
Device: Placebo stimulation
Placebo stimulation
Other Name: no 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01034150

Locations
Brazil
University of São Paulo/General Hospital
São Paulo, SP, Brazil, 55
Sponsors and Collaborators
University of Sao Paulo General Hospital
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
  More Information

No publications provided

Responsible Party: Adriana Bastos Conforto/ Staff neurologist, Hospital das Clinicas/University of Sao Paulo, Hospital das Clinicas/University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01034150     History of Changes
Other Study ID Numbers: 1309-06, 477916/06-6
Study First Received: December 11, 2009
Last Updated: December 16, 2009
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014