NIBS With mCIMT for Motor and Functional Upper Limb Recovery in Stroke Patients.

NACompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

June 4, 2018

Primary Completion Date

March 30, 2021

Study Completion Date

June 30, 2021

Conditions
StrokeUpper Extremity ParesisElectric StimulationOccupational Therapy
Interventions
DEVICE

Active Bihemispheric Transcranial direct current Stimulation

"The session will start with the application of the with a couple of surface sponge electrodes (25-35 cm2) on the scalp. The treatment modality will be as follows:~Active tDCS: The anodic electrode will be put on affected M1. The cathodic electrode will be put on contralateral M1. We will apply a constant current of 2mA of intensity during 20 minutes while the patient performs the occupational therapy session."

DEVICE

Sham Bihemispheric Transcranial direct current Stimulation

"The session will start with the application of the with a couple of surface sponge electrodes (25-35 cm2) on the scalp. The treatment modality will be as follows:~Sham tDCS: We will use the same place and parameters of stimulation applied for the active group, but the stimulator will deactivate after 30 seconds of stimulation. This will ensure that the patient will feel the initial tingling sensation at the beginning of the tDCS which is a requisite for blinding. The occupational therapy session will last one hour."

OTHER

Modified Constraint Induced Movement Therapy

"Both groups will perform the mCIMT during a period of seven consecutive days. This protocol consists of two elements:~1. Restriction of the movements of the non-affected hand by wearing a mitt during six hours a day: we will use a mitt that limits the movement of the fingers but allows the free movements of the wrist, elbow, and shoulder.~2. Intensive and individualized training of the affected arm during 2 hours a day guided by an occupational therapist: the two hours training will be divided into two sessions of one hour each. Sessions will be organized in three blocks: preparation, activation, and function. In the third block, devoted to function, the patient has to choose one activity of daily living that he wants to improve."

Trial Locations (2)

8380419

Hospital San José, Santiago

8380456

Hospital Clinico Universidad de Chile, Santiago

All Listed Sponsors
collaborator

Comisión Nacional de Investigación Científica y Tecnológica

OTHER_GOV

collaborator

Hospital San José

UNKNOWN

collaborator

Universidad Central de Chile

UNKNOWN

collaborator

Sociedad Chilena de Medicina Física y Rehabilitación

UNKNOWN

lead

University of Chile

OTHER

NCT03452254 - NIBS With mCIMT for Motor and Functional Upper Limb Recovery in Stroke Patients. | Biotech Hunter | Biotech Hunter