tDCS Combined With Constraint-Induced Therapy in Post-Stroke Upper Limb Rehabilitation

Summary

The objective of this clinical trial is to evaluate the effects of transcranial direct current stimulation (tDCS) combined with constraint-induced therapy (CIT) on upper limb motor recovery in individuals after stroke.

The main questions it aims to answer are:

Does the combination of tDCS and CIT improve upper limb motor function compared to CIT alone?

Does the combined intervention promote changes in muscle morphology and electromyographic activity?

Researchers will compare the group receiving tDCS combined with constraint-induced therapy to the group receiving constraint-induced therapy alone to determine whether the addition of cortical neuromodulation enhances motor recovery outcomes.

This is a randomized, controlled, and blinded clinical trial in which participants will be divided into two groups: one group will receive tDCS combined with CIMT, and the other will undergo only CIMT. The protocol will include 18 sessions over six weeks, three times a week.

Clinical and instrumental assessments will be performed before, during, and after the intervention, including the Fugl-Meyer scale for the upper limb, musculoskeletal ultrasound for morphological analysis, and surface electromyography for muscle activity assessment.

Conditions

• Stroke
• Upper Limb Motor Impairment
• Post-Stroke Hemiparesis

Interventions

DEVICE

transcranial direct current stimulation (tDCS)

For tDCS application, the Microestim tDCS model stimulator (NKL Electronic Products Ltd., Brazil) will be used, with a pair of 5 cm x 7 cm (35 cm2) sponge electrodes, which will be soaked in saline solution providing a current density of 0.04 mA/cm2 that will be within safety limits (Russo et al 2017). Regarding electrode placement, the anodic electrode will be fixed over the primary motor cortex (M1) of the affected hemisphere, corresponding to point C3 or C4, according to the international 10-20 electroencephalography system. The cathodic electrode will be positioned over the primary motor cortex of the unaffected hemisphere, at point C4 or C3, respectively, according to the same system. This choice was based on a study by Sun Ho et al (2021) that studied the effects of tDCS and ICT to improve upper limb function after stroke. Volunteers in the a-ETCC group will undergo anodal stimulation at M1 with constant direct current at an intensity of 2 mA, for 20 minutes per session.

BEHAVIORAL

Constraint-induced movement therapy

At the time of applying CIMT, a sling will be used positioned on the healthy upper limb (UL), then the affected or paretic UL will be stimulated to perform tasks involving activities of daily living and/or everyday life, with the volunteers seated, in an ergonomic way and with the material used for the activities positioned on a table. The healthy UL will be restrained by the sling, while the paretic UL will perform the activities. The CIMT protocol will involve three main components: repetitive task-oriented training of the affected upper limb; the transfer package, developed to facilitate the generalization of therapeutic gains obtained in the clinical setting to the participant's daily activities; and the restriction of the unaffected upper limb, with the aim of inducing functional use of the affected limb, as described in the classic study by Taub et al. (2006). It is worth noting that the restraint of the unaffected limb will occur exclusively during the intervention period

Sponsors & Collaborators

• Universidade do Estado do Pará

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-15

Primary Completion

2026-12-15

Completion

2027-04-10

Countries

• Brazil

Study Locations