Robotic Therapy and Brain Stimulation in the Early Phase After Stroke

NCT03230695 | Unknown

• 1 other identifier: RCT2129001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; robotic therapy; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• Movement Smoothness

  The speed shape, calculated as mean speed divided by peak speed.

  Kinematic assessment at baseline, immediately after intervention; and 24h after.

Secondary Outcomes (2)

• Number of peaks of the movement

  kinematic assessment at baseline, immediately after intervention; and 24h after.

• Jerk metric of the movement

  kinematic assessment at baseline, immediately after intervention; and 24h after

Study Arms (2)

Active stimulation + robotic therapy

ACTIVE COMPARATOR

Active transcranial direct current stimulation will be applied during 20 minutes prior to robotic training. Number of interventions sessions: 1

Device: Robotic Therapy; Device: Active stimulation

Sham stimulation + robotic therapy

SHAM COMPARATOR

Sham transcranial direct current stimulation will be applied during 20 minutes prior to robotic training. Number of interventions sessions: 1

Device: Robotic Therapy; Device: Sham stimulation

Interventions

Robotic Therapy DEVICE

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

Active stimulation + robotic therapy; Sham stimulation + robotic therapy

Active stimulation 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).

Active stimulation + robotic therapy

Sham stimulation DEVICE

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

Sham stimulation + robotic therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Suzana Bleckmann Reis

São Paulo, 05403900, Brazil

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Adriana B Conforto, D, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 26, 2017
• Study Start: August 3, 2017
• Primary Completion: December 1, 2024
• Study Completion: July 1, 2025
• Last Updated: October 28, 2022

Record last verified: 2022-10

Locations

BR (1)