Optimal Therapeutic Dose of tDCS for Functional Upper Limb Recovery in People With Stroke

Summary

Stroke is one of the main causes of disability worldwide. The main disability after a stroke is hemiparesis of an Upper Limb (UL), with a prevalence of 70%. Although conventional UL therapies achieve good recovery, their effectiveness is still limited since only 5 to 20% of patients manage to completely recover. This has led to the use of therapies in a combined manner in order to achieve greater benefit. Due to its effects on brain neuroplasticity processes, transcranial direct current stimulation (tDCS), a type of non-invasive brain stimulation, has begun to be used as a complement to standard UL therapies, including combined with Constraint Induced Movement Therapy, whether original or modified (CIMT-mCIMT), with which it shares neurological principles, with evidence of its benefits.

In patients with mild and moderate stroke, tDCS has been used with the aim of reestablishing the altered brain balance by reducing the hyperactivity of the unaffected hemisphere and/or activating the affected hemisphere. A recent meta-analysis mentions that tDCS plus other therapies improve the function of the UL. However, the high heterogeneity of the protocols does not allow us to know the optimal dose, which, in turn, makes decision making in clinical practice difficult. This makes it apropos to develop studies that define therapeutic doses. This would contribute to clinical guidelines and allow to optimize public resources in rehabilitation.

The present study aims to compare the evolution of functional recovery of the UL in people with subacute stroke who attend the Hospital Clínico de la Universidad de Chile and the Hospital San José, after receiving bi-hemispheric tDCS, administered through a protocol of 18 thirty-minute sessions (experimental group) versus a protocol of 18 twenty-minute sessions (active comparator group). The hypothesis is that the experimental group obtains at least 5% more functional recovery compared to the active comparator group. One of the secondary objectives is to identify in which session the recovery plateau is achieved. A randomized, double-blind clinical trial is proposed, where patients will be assigned either to the experimental or active comparator group and both will receive mCIMT as standard therapy. Clinical and socio-demographic information will be gathered and patients will be evaluated with UL motor and functional recovery scales, as well as an evaluation of independence in basic Activities of Daily Living (ADL), among others.

Conditions

• Stroke
• Neurologic Deficits

Interventions

DEVICE

Transcranial direct current stimulation

tDCS is a type of non-invasive brain stimulation that in a standard paradigm, low intensity current (1-2 mA) is applied continuously through a battery connected to two 20 to 35 cm2 surface electrodes located on the scalp: an anode and a cathode. In the interhemispheric competition model, tDCS can serve as a means to increase ipsilesional cortical excitability through anodal stimulation, to decrease contralesional cortical excitability through cathodal stimulation, or to do both through a montage of bi-hemispheric electrodes.

Sponsors & Collaborators

• Agencia Nacional de Investigación y Desarrollo

  collaborator OTHER

• University of Chile

  lead OTHER

Principal Investigators

• Maricel Garrido · University of Chile

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-01

Primary Completion

2025-11-28

Completion

2025-12-26