Robotic Therapy and Brain Stimulation in the Early Phase After Stroke

NCT ID: NCT03230695

Last Updated: 2022-10-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-03
• Study Completion Date: 2025-07-31

Brief Summary

Stroke is the second cause of death worldwide and the majority of the survivors remain with motor impairments. Inhibition of the motor cortex of the unaffected hemisphere has emerged as a potential intervention to enhance effects of other rehabilitation strategies on improvement of motor performance of the paretic upper limb. In this proof-of-concept study we will evaluate the effects of inhibition of the motor cortex of the unaffected hemisphere associated with robotic therapy on improvement of motor performance of the paretic upper limb in the early phase post-stroke.

Detailed Description

The main goal of this study is to test the proof of concept of benefits of inhibition of the motor cortex of the unaffected hemisphere on learning evaluated by improvement in kinematics of motor performance, in patients with upper limb paresis in the early phase post-stroke. For this purpose, patients will be randomized to receive real or sham transcranial direct current stimulation before a session of robotic therapy. Data will be collected by kinematic assessment performed automatically by the robot at baseline, immediately after and 24h after the intervention.

The working hypothesis is that one session of upper limb motor training will lead to improvement of performance in metrics of kinematics, and this improvement will be maintained up to 24h after the end of the training.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Active stimulation + robotic therapy

Active transcranial direct current stimulation will be applied during 20 minutes prior to robotic training.

Number of interventions sessions: 1

Group Type: ACTIVE_COMPARATOR

Robotic Therapy

Intervention Type: DEVICE

Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.

Active stimulation

Intervention Type: DEVICE

Active transcranial direct current stimulation will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).

Sham stimulation + robotic therapy

Sham transcranial direct current stimulation will be applied during 20 minutes prior to robotic training.

Number of interventions sessions: 1

Group Type: SHAM_COMPARATOR

Robotic Therapy

Intervention Type: DEVICE

Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.

Sham stimulation

Intervention Type: DEVICE

In sham transcranial direct current stimulation, no current will be delivered through the transcranial direct current stimulation device after the first 30 seconds.

Interventions

Robotic Therapy

Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.

Intervention Type: DEVICE

Active stimulation

Active transcranial direct current stimulation will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).

Intervention Type: DEVICE

Sham stimulation

In sham transcranial direct current stimulation, no current will be delivered through the transcranial direct current stimulation device after the first 30 seconds.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Ischemic or hemorrhagic stroke onset from 3 days to 9 weeks before, confirmed by computed tomography or magnetic resonance imaging.

Motor impairment of an upper limb, defined as a score between 1 - 3 in the Medical Research Council Scale, for at lest one the following movements: elbow extension, shoulder flexion, or shoulder extension.

Ability to provide written informed consent.

Ability to comply with the schedule of interventions and evaluations in the protocol.

Exclusion Criteria

Severe spasticity at the paretic elbow, wrist or fingers, defined as a score of > 3 in the Modified Ashworth Spasticity Scale.

No active shoulder and elbow movements

Uncontrolled medical problems such as end-stage cancer or renal disease

Pregnancy

Potential contraindications to transcranial direct current stimulation: history of seizures, lesions on the scalp, intracranial metal implants, prior intracranial surgery, use of drugs that interfere on cortical excitability (such as antiepileptic drugs, benzodiazepines)

Other neurological disorders such as Parkinson's disease

Psychiatric illness

Aphasia or severe cognitive deficits that compromise comprehension of the experimental protocol or ability to provide consent.

Hemineglect

Cerebellar lesions or on cerebellar pathways

Contact precautions

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adriana B Conforto, D, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Suzana Bleckmann Reis

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

RCT2129001

Identifier Type: -

Identifier Source: org_study_id