Back to results

Association Between Brain Stimulations for the Rehabilitation of Chronic Stroke Patients

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

tDCS

TMS

tDCS + TMS

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

Federal University of Health Sciences of Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

tDCS

rTMS

tDCS + rTMS

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

Motor Function by means of the Wolf Motor Function Test

Secondary Outcome Measures

Grip strength via hand dynamometer

Manual Dexterity by means of the Box and Block Test

Quality of Life by means of the Stroke Impact Scale

Full Information

NCT ID

NCT02817867

First Posted

June 27, 2016

Last Updated

June 12, 2019

Sponsor

Federal University of Health Science of Porto Alegre

1. Study Identification

Unique Protocol Identification Number

NCT02817867

Brief Title

Association Between Brain Stimulations for the Rehabilitation of Chronic Stroke Patients

Official Title

Association Between Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation for Chronic Stroke Patients Rehabilitation: a Randomized Clinical Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

June 2016 (undefined)

Primary Completion Date

October 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of Health Science of Porto Alegre

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

tDCS

Arm Type

Active Comparator

Arm Description

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

Arm Title

rTMS

Arm Type

Active Comparator

Arm Description

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

Arm Title

tDCS + rTMS

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

tDCS

Intervention Description

Transcranial direct current stimulation (tDCS)

Intervention Type

Device

Intervention Name(s)

TMS

Intervention Description

Transcranial magnetic stimulation

Intervention Type

Device

Intervention Name(s)

tDCS + TMS

Intervention Description

Association between tDCS and TMS.

Primary Outcome Measure Information:

Title

Motor Function by means of the Wolf Motor Function Test

Time Frame

change from pre to post (at least 10 days)

Secondary Outcome Measure Information:

Title

Grip strength via hand dynamometer

Time Frame

change from pre to post (at least 10 days)

Title

Manual Dexterity by means of the Box and Block Test

Time Frame

change from pre to post (at least 10 days)

Title

Quality of Life by means of the Stroke Impact Scale

Time Frame

change from pre to post (at least 10 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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;

Facility Information:

Facility Name

Federal University of Health Sciences of Porto Alegre

City

Porto Alegre

State/Province

Rio Grande Do Sul

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

Association Between Brain Stimulations for the Rehabilitation of Chronic Stroke Patients

We'll reach out to this number within 24 hrs