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Completed

NCT Number: NCT02455427

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danielle Boasquevisque

São Paulo, 05652-901, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Physical Therapy

Other

Physical therapy will be administered for 60 minutes

Sham tDCS

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Registry information

Acronym: NEUROSTIM

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 27, 2015
Registry last updated
Sep 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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