Clinical trial NCT02455427: Safety of Transcranial Direct Current Stimulation in the Subacute Phase After Stroke
Official title: Safety of Transcranial Direct Current Stimulation in the Subacute Phase After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: transcranial direct current stimulation
conventional physical therapy
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: Safety of the intervention as assessed by frequency of adverse events
timeFrame: 2 weeks
Secondary outcomes:
measure: Improvement post treatment as measured by the Modified Rankin Scale
timeFrame: 2 weeks and 14 weeks
measure: Improvement post treatment as measured by the NIH Stroke Scale
timeFrame: 2 weeks and 14 weeks
measure: Improvement post treatment as measured by the Stroke Impact Scale
timeFrame: 2 weeks and 14 weeks
measure: Upper limb subscale of Fugl Meyer Assessment of Sensorimotor recovery after stroke
timeFrame: 2 weeks and 14 weeks
measure: Improvement post treatment as measured by the Modified Ashworth Scale
timeFrame: 2 weeks and 14 weeks
measure: Improvement post treatment as measured by the Motor Activity Log
timeFrame: 2 weeks and 14 weeks
measure: Montreal Cognitive Assessment Test
timeFrame: 2 weeks and 14 weeks
measure: Structural Connectivity as measured by diffusion tensor imaging analysis
timeFrame: 2 weeks
measure: Functional Connectivity as measured by resting-state functional magnetic imaging analysis
timeFrame: 2 weeks
measure: Improvement post treatment as measured by the Barthel index
timeFrame: 2 week and 14 weeks
measure: Safety of the intervention as assessed by frequency of adverse events
timeFrame: 14 weeks
measure: Improvement post treatment as measured by Pittsburgh Sleep Quality Index
timeFrame: 2 week and 14 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Danielle Boasquevisque
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Adriana B Conforto, MD Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.