Effect of Transcranial Direct Current Stimulation (tDCS) on Post-stroke Patients on Neuromotor Recovery

I.R.C.C.S. Fondazione Santa Lucia

Status: Completed

Conditions: Stroke

Treatments: Other: Conventional rehabilitative treatment; Device: tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT05821816

Prot. CE/2022_031

Details and patient eligibility

About

The aim of the study is to evaluate whether a non-invasive brain stimulation technique (Transcranial Direct Current Stimulation) can influence the secondary neurodegeneration observed after a stroke (assessed based on serum concentration of neurofilaments) and can improve the functional outcome.

Full description

The present preliminary study aims to evaluate the effects of tDCS (transcranial direct current stimulation) on functional recovery in subacute stroke patients and on neurodegeneration, measuring Neurofilament light chain (NfL) in blood.

It will evaluate:

• baseline NfL levels in patients with subacute stroke;
• the correlation between motor recovery and the blood concentration of NfL in subjects treated with tDCS compared to the control group.
• the effect of tDCS on motor recovery and NfL levels in the 3 months after the stroke event;

Enrollment: 50 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• partecipants with a first episode of ischemic or hemorrhagic stroke
• partecipants must be enrolled within 30 days from the stroke

Exclusion criteria

• partecipants with previous episodes of ischemic or hemorrhagic stroke (evaluation by neuroimaging required)
• uncooperative patients
• medically unstable patients
• partecipants with any other neurodegenerative diseases
• epilepsies
• multiple ischemic lesions
• encephalic trunk ischemic lesions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Experimental Group

Experimental group

Description:

Standard rehabilitative treatment for stroke + tDCS

Treatment:

Device: tDCS

Other: Conventional rehabilitative treatment

Control Group

Active Comparator group

Description:

Only standard rehabilitative treatment for stroke

Treatment:

Other: Conventional rehabilitative treatment