Combined Brain and Peripheral Nerve Stimulation for Stroke

NCT01907737 | Completed Results DMC

• 1 other identifier: P0546/11
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebrovascular disease is a major cause of disability worldwide. The catastrophic burden of stroke is more dramatic in low- and middle- income countries, and the scarcity of evidence-based rehabilitation interventions represents a major challenge to global health care. Upper limb weakness is frequent after stroke, but there is no universally accepted treatment to effectively improve hand function in patients with moderate and severe motor impairment. These are the patients in deepest need of rehabilitative interventions. This project addresses this important issue, by testing effects of a novel approach. We will non-invasively stimulate the brain and peripheral nerves in order to enhance effects of motor training aided by an electrical stimulation device in patients with moderate to severe hand weakness. Our hypothesis is that brain stimulation, when added to peripheral nerve stimulation, will enhance effects of motor training to a greater extent than brain stimulation alone, peripheral stimulation alone, or no stimulation.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Active Range of Motion of Wrist Extension in the Paretic Side

  In this cross-over study, the primary outcome was measured immediately before and after each session of treatment. In each session, one of the four possible interventions was administered.

  Pre- and post-intervention on each intervention day

Study Arms (4)

Active tDCS and active PNS

ACTIVE COMPARATOR

1 session of active transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and active peripheral nerve stimulation (PNS)

Other: Active tDCS; Other: Active PNS

Active tDCS and sham PNS

OTHER

1 session of active transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and sham peripheral nerve stimulation (PNS)

Other: Active tDCS; Other: Sham PNS

Sham tDCS and active PNS

OTHER

1 session of sham transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and active peripheral nerve stimulation (PNS)

Other: Active PNS; Other: Sham tDCS

Sham tDCS and sham PNS

SHAM COMPARATOR

1 session of sham transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and sham peripheral nerve stimulation (PNS)

Other: Sham tDCS; Other: Sham PNS

Interventions

Active tDCS OTHER

Active tDCS will be applied with the anode positioned over the ipsilesional M1 and the cathode over the contralateral supraorbital region for 20 minutes (1mA).

Active tDCS and active PNS; Active tDCS and sham PNS

Active PNS OTHER

Active PNS will be administered by 2 pairs of surface electrodes (cathode proximal). One pair will overly the median and ulnar nerves at the wrist, and the other pair will overly the radial nerve. Trains of electric stimulation will be delivered at 1 Hz by using isolation units connected to a square pulse stimulator.

Active tDCS and active PNS; Sham tDCS and active PNS

Sham tDCS OTHER

In sham tDCS, no current will be delivered through the tDCS device.

Sham tDCS and active PNS; Sham tDCS and sham PNS

Sham PNS OTHER

No current will be delivered to the radial, ulnar and median nerves.

Active tDCS and sham PNS; Sham tDCS and sham PNS

Eligibility Criteria

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

You may qualify if:

• Age, 18 years or older;
• First-ever, ischemic or hemorrhagic stroke at least six months before, confirmed by computed tomography or magnetic resonance imaging;
• Moderate to severe motor impairment of an upper limb, defined as a score between 7 and 50 on the Fugl-Meyer Assessment of Sensorimotor Recovery after stroke, a scale with scores for upper limb ranging from 0 (no function) to 66 (normal function;
• Ability to provide written Informed Consent (patient or legal representative);
• Ability to comply with the schedule of interventions and evaluations in the protocol.

You may not qualify if:

• Lack of ability to voluntarily activate any active range of wrist extension;
• Anesthesia of the paretic hand;
• Stroke lesions affecting entirely the hand knob area of the motor cortex120;
• Stroke lesions affecting the cerebellum or the brain stem;
• Severe spasticity at the paretic elbow, wrist, or fingers, defined as a score of \>3 on the Modified Ashworth Spasticity Scale;
• Active joint deformity;
• Uncontrolled medical problems such as end-stage cancer or renal disease;
• Pregnancy;
• Seizures;
• Pacemakers;
• Other neurological disorders such as Parkinson's disease;
• Psychiatric illness including severe depression;
• Aphasia or serious cognitive deficits that preclude comprehension of the experimental protocol or ability to provide consent. A score in the Minimental State Examination lower than 23/30 points will be used for patients with higher than 1 year of education, and a score lower than 19/30 will be used for patients with 1 year of education or less.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação Faculdade de Medicina: collaborator

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo/Fundação Faculdade de Medicina

São Paulo, São Paulo, 05403000, Brazil

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Adriana Conforto
• Organization: HCFMUSP/FFM

adriana.conforto@gmail.com

551126617955

Study Officials

• Adriana Conforto, MD PhD

  Instituto do Coracao

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2013
• First Posted: July 25, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 19, 2019
• Results First Posted: July 19, 2019

Record last verified: 2019-05

Locations

BR (1)