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OpenTrials
Completed

NCT Number: NCT02817867

Association Between Brain Stimulations for the Rehabilitation of Chronic Stroke Patients

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

tDCS

Device

Transcranial direct current stimulation (tDCS)

TMS

Device

Transcranial magnetic stimulation

tDCS + TMS

Device

Association between tDCS and TMS.

Primary outcomes

  1. Motor Function by means of the Wolf Motor Function Test

    Time frame: change from pre to post (at least 10 days)

Secondary outcomes

  1. Grip strength via hand dynamometer

    Time frame: change from pre to post (at least 10 days)

  2. Manual Dexterity by means of the Box and Block Test

    Time frame: change from pre to post (at least 10 days)

  3. Quality of Life by means of the Stroke Impact Scale

    Time frame: change from pre to post (at least 10 days)

Sponsors and collaborators

Lead sponsor

Federal University of Health Science of Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 29, 2016
Registry last updated
Jun 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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