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

Stroke Clinical Trial

— NEUROSTIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02455427
• Other study ID #: 225014
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: March 31, 2018

Study information

• Verified date: September 2018
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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

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

Locations

Country	Name	City	State
Brazil	Danielle Boasquevisque	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

Outcome

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