Association Between Brain Stimulations for the Rehabilitation of Chronic Stroke Patients

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: tDCS + TMS; Device: tDCS; Device: TMS

• Registration Number: NCT02817867
• Lead Sponsor: Federal University of Health Science of Porto Alegre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-06-27
• Study First Posted: 2016-06-29
• Primary Completion: 2017-10
• Study Completion: 2017-12
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-12
• Last Update Posted: 2019-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• 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.

Exclusion Criteria

• 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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tDCS + rTMS	tDCS + TMS	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.
tDCS	tDCS	Patients who will be treated with Transcranial direct-current stimulation (tDCS) in the ipsilesional motor cortex.
rTMS	TMS	Patients who will be treated with Magnetic brain stimulation (rTMS) in the contralesional motor cortex.

Primary Outcome Measures

Name	Time	Method
Motor Function by means of the Wolf Motor Function Test	change from pre to post (at least 10 days)

Secondary Outcome Measures

Name	Time	Method
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)
Grip strength via hand dynamometer	change from pre to post (at least 10 days)

Trial Locations

Locations (1)

Federal University of Health Sciences of Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil