Multicenter Study on the Efficacy of Transcranial Direct Current Stimulation (tDCS) in Post-stroke Motor Recovery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-10

Study Completion Date

2020-12-31

Brief Summary

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Several previous studies have used tDCS as a neuromodulation tool, showing improvements in several diseases (Lefaucheur et al., 2017). Based on these observations, it is believed that the use of tDCS in combination with specific motor training may provide the opportunity to induce behavioral improvements in patients with motor deficits. As shown in previous reports brain stimulation can, in fact, interact with the intrinsic ability of the brain to "repair" damaged brain functions, increasing the involvement of compensatory functional networks and thus inducing neuroplasticity. If these low-cost, easy-to-use stimulation techniques prove to be useful in improving motor deficits with long-term effects, the current study would open up new and interesting avenues in the field of neurorehabilitation. Given the potential long-lasting effects of tDCS, there is currently a growing interest in the clinical sector with the aim to reduce motor deficits in patients with brain injury. The most widely used protocols in stroke patients include the application of either anodal on the hypsilesional hemisphere or cathodal tDCS on the unaffected hemisphere (contralateral), so as to increase and decrease the excitability of the motor cortex, respectively (Nitsche and Paulus, 2001).

The main objective of this study is to evaluate the effectiveness of transcranial direct current stimulation in enhancing the functional recovery of the upper limb of stroke patients after three weeks of neuromotor training and subsequent follow-up. The secondary objective is to evaluate the treatment effects on balance, gait, motor dexterity and disability, besides the functional recovery of the lower limb.

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Detailed Description

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Conditions

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Stroke, Ischemic Stroke Hemorrhagic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The present study will be conducted in over 15 recruiting centers with a randomized double-blind design. Post-stroke patients will be randomly assigned to 3 parallel groups: Control Group (neuromotor training and sham stimulation), Experimental Group 1 (neuromotor training and cathodal tDCS over the unaffected hemisphere), Group 2 (neuromotor training and anodal tDCS over the affected hemisphere). Participants will be further partitioned on the basis of the acute/subacute and subacute/chronic stages (7-90 and 91 days from lesion onset, respectively).

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Both participants and experimenters will be prevented from having knowledge of the assigned stimulation protocol. To do so, the investigator will create a series of numbers paired with real and sham interventions while the outcome assessor will be aware of the patient-number association only.

Study Groups

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Control Group

neuromotor training and placebo stimulation

Group Type SHAM_COMPARATOR

Sham stimulation (sham-tDCS)

Intervention Type DEVICE

placebo stimulation

Neuromotor training

Intervention Type BEHAVIORAL

conventional neuromotor treatment

Group 1

neuromotor training and cathodal stimulation over the unaffected hemisphere

Group Type EXPERIMENTAL

Cathodal transcranial direct current stimulation (C-tDCS)

Intervention Type DEVICE

Cathodal tDCS will be performed for 20 minutes over the unaffected hemisphere with an intensity set to 2 mA

Neuromotor training

Intervention Type BEHAVIORAL

conventional neuromotor treatment

Group 2

neuromotor training and anodal stimulation over the affected hemisphere

Group Type EXPERIMENTAL

Anodal transcranial direct current stimulation (A-tDCS)

Intervention Type DEVICE

Anodal tDCS will be performed for 20 minutes over the affected hemisphere with an intensity set to 2 mA

Neuromotor training

Intervention Type BEHAVIORAL

conventional neuromotor treatment

Interventions

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Anodal transcranial direct current stimulation (A-tDCS)

Anodal tDCS will be performed for 20 minutes over the affected hemisphere with an intensity set to 2 mA

Intervention Type DEVICE

Cathodal transcranial direct current stimulation (C-tDCS)

Cathodal tDCS will be performed for 20 minutes over the unaffected hemisphere with an intensity set to 2 mA

Intervention Type DEVICE

Sham stimulation (sham-tDCS)

placebo stimulation

Intervention Type DEVICE

Neuromotor training

conventional neuromotor treatment

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* First-ever ischemic stroke
* Red or white stroke
* Barthel Index \> 90 before lesion onset

Exclusion Criteria

* Previous inborn neurological disease
* Previous acquired neurological disease
* Previous or current major psychiatric illness
* Epilepsy or anticonvulsant treatment
* Use of calcium channel blocker drugs
* Treatments with other technologies (robotics, FES, etc.)
* Neurolytic treatments with botulinum toxin

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No