Feasibility and Effectiveness of tDCS in the Treatment of Post-stroke Fatigue (EFECTS).

Hospital Clinic of Barcelona

Status: Enrolling

Conditions: Stroke

Treatments: Device: tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT06149897

HCB/2022/1193

Details and patient eligibility

About

This study aims to analyze the use of non-invasive brain stimulation (tDCS) is beneficial for the treatment of post-stroke fatigue.

Full description

A single-blind randomized clinical trial will be conducted. The intervention will consist of 8 20-minute tDCS sessions conducted over four weeks. The stimulation will be performed by applying the stimulation to the dorsolateral prefrontal cortex on the left side (F3) and the cathode will be at point O2 of the right hemisphere. The study will consist of two groups: the control group in which sham stimulation will be applied and therapeutic education and aerobic exercise; the intervention group in which stimulation, therapeutic education and therapeutic exercise will be carried out.

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• First stroke within 45 (+-7) days of the ischemic or hemorrhagic episode.
• Ability to understand and execute simple instructions
• Over 18 years.
• Fatigue Scale of fatigue severity with a score greater than or equal to 24

Exclusion criteria

• A score > 2 on the modified Rankin Scale (mRS) before the stroke.
• Patients with decompensated cardiorespiratory and/or psychiatric pathology.
• Comorbidity causing disproportionate fatigue, such as long-term COVID.
• Patients who are cancer survivors or who are undergoing cancer treatment.
• Patients with a history of epilepsy or who are taking antiepileptic medication.
• Patents with major depression.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups

Control group

Sham Comparator group

Description:

* Therapeutic education about post-stroke fatigue * Sham stimulation with tDCS: Anode placed in F3 and cathode in O2, 20 minutes. * Aerobic exercise measured with Borg scale (moderate intensity)

Treatment:

Device: tDCS

Experimental group

Active Comparator group

Description:

* Therapeutic education about post-stroke fatigue * Stimulation with tDCS: Anode placed in F3 and cathode in O2, intensity 2mA during 20 minutes. * Aerobic exercise measured with Borg scale (moderate intensity)

Treatment:

Device: tDCS