tDCS in Post-stroke Neglect Rehabilitation

Summary

Introduction

Stroke is the main cause of disability in the world and its sequelae have a great impact in the functional independence and quality of life of patients and families. Unilateral spatial neglect is one of the most frequent cognitive deficits after stroke, and its maintenance is associated with poor functional outcome of the rehabilitation process.

For many years clinical research has been conducted to develop new and effective rehabilitation strategies for neglect. Noninvasive brain stimulation (NIBS) techniques are important tools in this regard, and it should be considered as a therapeutic intervention used in combination with conventional neuropsychological approaches. Transcranial direct current stimulation (tDCS) is a noninvasive, safe, neurophysiological technique able to modulate cortical activity by inducing a weak electric current into the brain.

The studies focused on neglect symptoms treatment by means of tDCS over the lesional and contralesional hemisphere have shown promising results and its combination with conventional neglect therapies may enhance treatment efficacy and speed the recovery.

Objectives

To improve neglect symptoms by reducing the pathological hyperactivity of the undamaged hemisphere after right medial cerebral artery stroke, through the application of multisite tDCS, and to validate a NIBS protocol for the enhancement of conventional neuropsychological rehabilitation outcome.

Methods

The sample will be composed by 30 patients with spatial neglect secondary to a ischemic stroke in the middle cerebral artery in subacute stage (3 to 12 months since the event). The patients will be randomly assigned to one experimental group (Active, Sham, and Control).

The intervention protocol consists in a two weeks intervention (10 sessions, 45 min, Monday to Friday) of tDCS and neuropsychological rehabilitation applied concurrently. In each session a 20 min tDCS at 2 milliamps (m will be applied over P3 according to 10/20 EEG international system (cathodal) with return electrodes placed in C3,CP5,CP1,Pz,PO3,PO7,P7 (10/20 EEG). StarStim® tDCS 8 channels Multisite device will be used.

Conditions

• Stroke
• Neglect, Hemispatial

Interventions

DEVICE

Transcranial direct current stimulation

The intervention consists in two-weeks treatment, 10 consecutive sessions of tDCS ( Monday to Friday) applied concurrently to neuropsychological rehabilitation. The tDCS Multisite StratStim® 8-channel device (Neuroelectrics) will be used for tDCS stimulation. The duration of the stimulation will be 20 minutes at 2 mA. The tDCS will be applied with the cathode positioned in P3 (following the international 10/20 EEG system), and the return electrodes will be placed in C3, CP5, CP1, Pz, PO3, PO7, P7. The sessions will last 1 hour.

PROCEDURE

Neuropsychological rehabilitation

The neuropsychological rehabilitation protocol has been designed for the recovery of neglect symptomatology. Each session will consist on the performance of different cognitive stimulation tasks aimed at improving attention and visoperceptive abilities. The tasks will be applied through the NeuronUp neurorehabilitation platform in order to achieve maximum homogeneity and objectivity across patients. The neuropsychological rehabilitation will last 30min (in 1h intervention session).

Sponsors & Collaborators

• Hospital Beata María Ana

  collaborator OTHER

• Universidad Francisco de Vitoria

  collaborator OTHER

• Universitat Oberta de Catalunya

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-08

Primary Completion

2023-11-30

Completion

2023-11-30

Countries

• Spain

Study Locations