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

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).

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Sham tDCS; Device: Active tDCS; Other: Physical Therapy

Detailed Description

The investigators main goal is to confirm the safety of transcranial direct current stimulation (tDCS) associated with conventional physical therapy, compared to conventional physical therapy associated with sham tDCS, for upper limb rehabilitation in an early phase (72 hours until 6 weeks) after stroke. Patients will be randomized to receive one of these two treatments, 3 times per week, for 2 weeks. Adverse effects will be monitored during each session. The working hypothesis is that conventional physical therapy associated with active tDCS in the subacute phase of ischemic stroke will be as safe as conventional therapy alone. The investigators will also preliminarily evaluate the efficacy of active tDCS associated with conventional therapy, compared to conventional therapy alone, in improvement of upper limb motor impairment. The investigators secondary goals are: 1) To compare effects of the above mentioned interventions on disability, spasticity and quality of life, in patients at an early stage after stroke ( subacute phase), immediately after treatment and 3 months later. The investigators hypothesis is that the association of conventional physical therapy and active tDCS will lead to better outcomes than conventional therapy alone. Patients will be assessed before the first session and after the last session of treatment, as well as 3 months after the last session of treatment.

Preliminary data about structural and functional connectivity will be collected in order to plan future studies related to mechanisms of tDCS in the subacute phase after stroke.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05652-901
    • Danielle Boasquevisque

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active tDCS+ Physical Therapy; 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; 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).; Other: Physical Therapy; Physical therapy will be administered for 60 minutes
Sham Comparator: Sham tDCS+Physical Therapy; 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)	Device: Sham tDCS; In sham tDCS, no current will be delivered through the tDCS device.; Other: Physical Therapy; Physical therapy will be administered for 60 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the intervention as assessed by frequency of adverse events	frequency of adverse events in the active and sham arms	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement post treatment as measured by the Modified Rankin Scale	Improvement post treatment	2 weeks and 14 weeks
Improvement post treatment as measured by the NIH Stroke Scale	Improvement post treatment	2 weeks and 14 weeks
Improvement post treatment as measured by the Stroke Impact Scale	Improvement post treatment	2 weeks and 14 weeks
Upper limb subscale of Fugl Meyer Assessment of Sensorimotor recovery after stroke	Improvement post treatment	2 weeks and 14 weeks
Improvement post treatment as measured by the Modified Ashworth Scale	Improvement post treatment	2 weeks and 14 weeks
Improvement post treatment as measured by the Motor Activity Log	Improvement post treatment	2 weeks and 14 weeks
Montreal Cognitive Assessment Test	No cognitive deterioration post treatment	2 weeks and 14 weeks
Structural Connectivity as measured by diffusion tensor imaging analysis	Improvement post treatment	2 weeks
Functional Connectivity as measured by resting-state functional magnetic imaging analysis	Improvement post treatment	2 weeks
Improvement post treatment as measured by the Barthel index	Improvement post treatment	2 week and 14 weeks
Safety of the intervention as assessed by frequency of adverse events	frequency of adverse events in the active and sham arms	14 weeks
Improvement post treatment as measured by Pittsburgh Sleep Quality Index	Improvement post treatment	2 week and 14 weeks

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Investigators: Principal Investigator: Adriana B Conforto, MD Phd, Hospital Israelita Albert Einstein

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): March 31, 2018
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: April 24, 2015
• First Submitted That Met QC Criteria: May 22, 2015
• First Posted (Estimate): May 27, 2015

Study Record Updates

• Last Update Posted (Actual): September 27, 2018
• Last Update Submitted That Met QC Criteria: September 25, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: transcranial direct current stimulation; conventional physical therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 225014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Deidentified imaging data will be shared with collaborators