Association Between Brain Stimulations for the Rehabilitation of Chronic Stroke Patients

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02817867
• Other study ID #: APPG-2016
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2017

Study information

• Verified date: June 2019
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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;

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• tDCS
Transcranial direct current stimulation (tDCS)
• TMS
Transcranial magnetic stimulation
• tDCS + TMS
Association between tDCS and TMS.

Locations

Country	Name	City	State
Brazil	Federal University of Health Sciences of Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor Function by means of the Wolf Motor Function Test		change from pre to post (at least 10 days)
Secondary	Grip strength via hand dynamometer		change from pre to post (at least 10 days)
Secondary	Manual Dexterity by means of the Box and Block Test		change from pre to post (at least 10 days)
Secondary	Quality of Life by means of the Stroke Impact Scale		change from pre to post (at least 10 days)