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

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ClinicalTrials.gov Identifier: NCT02455427
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital Israelita Albert Einstein

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).


Condition or disease Intervention/treatment Phase
Stroke Device: Active tDCS Other: Physical Therapy Device: Sham tDCS Not Applicable

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  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety of Transcranial Direct Current Stimulation in the Subacute Phase After Stroke
Study Start Date : May 2015
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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)

Other: Physical Therapy
Physical therapy will be administered for 60 minutes

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




Primary Outcome Measures :
  1. Safety of the intervention as assessed by frequency of adverse events [ Time Frame: 2 weeks ]
    frequency of adverse events in the active and sham arms


Secondary Outcome Measures :
  1. Improvement post treatment as measured by the Modified Rankin Scale [ Time Frame: 2 weeks and 14 weeks ]
    Improvement post treatment

  2. Improvement post treatment as measured by the NIH Stroke Scale [ Time Frame: 2 weeks and 14 weeks ]
    Improvement post treatment

  3. Improvement post treatment as measured by the Stroke Impact Scale [ Time Frame: 2 weeks and 14 weeks ]
    Improvement post treatment

  4. Upper limb subscale of Fugl Meyer Assessment of Sensorimotor recovery after stroke [ Time Frame: 2 weeks and 14 weeks ]
    Improvement post treatment

  5. Improvement post treatment as measured by the Modified Ashworth Scale [ Time Frame: 2 weeks and 14 weeks ]
    Improvement post treatment

  6. Improvement post treatment as measured by the Motor Activity Log [ Time Frame: 2 weeks and 14 weeks ]
    Improvement post treatment

  7. Montreal Cognitive Assessment Test [ Time Frame: 2 weeks and 14 weeks ]
    No cognitive deterioration post treatment

  8. Structural Connectivity as measured by diffusion tensor imaging analysis [ Time Frame: 2 weeks ]
    Improvement post treatment

  9. Functional Connectivity as measured by resting-state functional magnetic imaging analysis [ Time Frame: 2 weeks ]
    Improvement post treatment

  10. Improvement post treatment as measured by the Barthel index [ Time Frame: 2 week and 14 weeks ]
    Improvement post treatment

  11. Safety of the intervention as assessed by frequency of adverse events [ Time Frame: 14 weeks ]
    frequency of adverse events in the active and sham arms

  12. Improvement post treatment as measured by Pittsburgh Sleep Quality Index [ Time Frame: 2 week and 14 weeks ]
    Improvement post treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02455427


Locations
Brazil
Danielle Boasquevisque
Sao Paulo, Brazil, 05652-901
Sponsors and Collaborators
Hospital Israelita Albert Einstein
Investigators
Principal Investigator: Adriana B Conforto, MD Phd Hospital Israelita Albert Einstein

Responsible Party: Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT02455427     History of Changes
Other Study ID Numbers: 225014
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Deidentified imaging data will be shared with collaborators

Keywords provided by Hospital Israelita Albert Einstein:
transcranial direct current stimulation
conventional physical therapy

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases