Association Between Brain Stimulations for the Rehabilitation of Chronic Stroke Patients

NCT02817867 | Completed

• 1 other identifier: APPG-2016
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebrovascular accident (CVA) is a cerebrovascular disease with high incidence and morbidity in the Brazilian population, and is considered a major cause of disability in adults. Brain damage caused by stroke generates a maladaptive pattern of neural activity and modulation between the cerebral hemispheres, unbalancing in the inter-hemispheric inhibition. This condition affects patient's functional recovery. The aim of this study is to verify the effectiveness of repetitive transcranial magnetic stimulation Association (rTMS) in the cortex motor contralesional, Transcranial Direct Current Stimulation (tDCS) in the motor cortex ipsilesional and the association between these two types of brain stimulations on the upper limb recovery after stroke.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Motor Function by means of the Wolf Motor Function Test

  change from pre to post (at least 10 days)

Secondary Outcomes (3)

• Grip strength via hand dynamometer

  change from pre to post (at least 10 days)

• Manual Dexterity by means of the Box and Block Test

  change from pre to post (at least 10 days)

• Quality of Life by means of the Stroke Impact Scale

  change from pre to post (at least 10 days)

Study Arms (3)

tDCS

ACTIVE COMPARATOR

Patients who will be treated with Transcranial direct-current stimulation (tDCS) in the ipsilesional motor cortex.

Device: tDCS

rTMS

ACTIVE COMPARATOR

Patients who will be treated with Magnetic brain stimulation (rTMS) in the contralesional motor cortex.

Device: TMS

tDCS + rTMS

EXPERIMENTAL

Patients who will be treated with the association between Transcranial direct-current stimulation (tDCS) and magnetic brain stimulation (rTMS), in the ipsilesional and contralesional motor cortex, respectively.

Device: tDCS + TMS

Interventions

tDCS DEVICE

Transcranial direct current stimulation (tDCS)

tDCS

TMS DEVICE

Transcranial magnetic stimulation

rTMS

tDCS + TMS DEVICE

Association between tDCS and TMS.

tDCS + rTMS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subcortical stroke diagnosis, which has resulted in hemiparesis for at least 6 months and not more than 5 years (chronic condition);
• Ability to reach 60 degrees in the shoulder flexion
• Ability to completely extend the fingers in the affected upper limb;
• Minimal cognitive ability to understand commands;
• No current use of antiepileptic drugs for seizures.

You may not qualify if:

• Painful shoulder, adhesive capsulitis or glenohumeral subluxation;
• Contraindication (presence of metallic implants) or risks for the Transcranial magnetic stimulation, as evaluated by means of a standard questionnaire;

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (1)

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation; Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Magnetic Field Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: June 29, 2016
• Study Start: June 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 13, 2019

Record last verified: 2019-06

Locations

BR (1)