Safety of Transcranial Direct Current Stimulation in the Subacute Phase After Stroke

NCT02455427 | Completed DMC

• 1 other identifier: 225014
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is the second cause of death worldwide and represented the first cause of death in Brazil between 2006 and 2010. Most patients survive, and there is a need to develop cost-effective rehabilitation strategies to decrease the burden of disability from stroke. This study addresses this important issue, by evaluating, in the early phase post-stroke, effects of motor conventional physical therapy associated or not with transcranial direct current stimulation (tDCS).

Conditions

Stroke

Keywords

transcranial direct current stimulation; conventional physical therapy

Outcome Measures

Primary Outcomes (1)

• Safety of the intervention as assessed by frequency of adverse events

  frequency of adverse events in the active and sham arms

  2 weeks

Secondary Outcomes (12)

• Improvement post treatment as measured by the Modified Rankin Scale

  2 weeks and 14 weeks

• Improvement post treatment as measured by the NIH Stroke Scale

  2 weeks and 14 weeks

• Improvement post treatment as measured by the Stroke Impact Scale

  2 weeks and 14 weeks

• Upper limb subscale of Fugl Meyer Assessment of Sensorimotor recovery after stroke

  2 weeks and 14 weeks

• Improvement post treatment as measured by the Modified Ashworth Scale

  2 weeks and 14 weeks

Study Arms (2)

Active tDCS+ Physical Therapy

ACTIVE COMPARATOR

Active tDCS (transcranial direct current stimulation) will be applied for 20 minutes. After active session of tDCS, the patient will receive physical therapy for 60 minutes. Number of treatment sessions: 6 (3 times a week, for 2 weeks)

Device: Active tDCS; Other: Physical Therapy

Sham tDCS+Physical Therapy

SHAM COMPARATOR

Sham tDCS (transcranial direct current stimulation) will be applied for 20 minutes. After sham session of tDCS, the patient will receive physical therapy for 60 minutes. Number of treatment sessions: 6 (3 times a week, for 2 weeks)

Other: Physical Therapy; Device: Sham tDCS

Interventions

Active tDCS DEVICE

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

Active tDCS+ Physical Therapy

Physical Therapy OTHER

Physical therapy will be administered for 60 minutes

Active tDCS+ Physical Therapy; Sham tDCS+Physical Therapy

Sham tDCS DEVICE

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

Sham tDCS+Physical Therapy

Eligibility Criteria

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

You may qualify if:

• Ischemic stroke confirmed by computed tomography or magnetic resonance imaging, with onset between 72 hours and 6 weeks before enrollment.
• Unilateral paresis of upper limb
• National Institute of Health Stroke Scale ( NIHSS) score of at least 1 point in items 5a or 5b .
• Ability to provide written informed consent (patient ou legal representative).

You may not qualify if:

• Lesions affecting the corticomotor pathway in the hemisphere contralateral to the stroke.
• Neurologic diseases except migraine.
• Modified Rankin Scale \> 2 prior to stroke.
• Advanced systemic disease such as cancer or advanced chronic renal disease.
• Clinical instability such as uncontrolled cardiac arrhythmia or heart failure.
• Contraindication for physical therapy.
• Pregnancy.
• Absolute or relative contraindications to tDCS: metallic prosthesis in the head or neck; lesions on the scalp, history of neurosurgery, pacemaker.
• Comprehension aphasia
• Dementia
• Cerebellar stroke or ataxia caused by involvement of cerebellar pathways in the brainstem

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Danielle Boasquevisque

São Paulo, 05652-901, Brazil

Location

Related Publications (2)

• Takahashi MTC, Balardin JB, Bazan PR, Boasquevisque DS, Amaro Junior E, Conforto AB. Effect of transcranial direct current stimulation in the initial weeks post-stroke: a pilot randomized study. Einstein (Sao Paulo). 2024 Jun 24;22:eAO0450. doi: 10.31744/einstein_journal/2024AO0450. eCollection 2024.

  PMID: 38922218 DERIVED

• Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.

  PMID: 33175411 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Adriana B Conforto, MD Phd

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 24, 2015
• First Posted: May 27, 2015
• Study Start: May 1, 2015
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: September 27, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)