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

NCT ID: NCT06149897

Last Updated: 2025-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-10

Study Completion Date

2026-02-05

Brief Summary

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

Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control group

* 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)

Group Type SHAM_COMPARATOR

tDCS

Intervention Type DEVICE

Non invasive brain stimulation with sham and active comparators

Experimental group

* 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)

Group Type ACTIVE_COMPARATOR

tDCS

Intervention Type DEVICE

Non invasive brain stimulation with sham and active comparators

Interventions

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tDCS

Non invasive brain stimulation with sham and active comparators

Intervention Type DEVICE

Other Intervention Names

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physical exercise therapeutic education

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Inés García Bouyssou

Physical therapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Clínic de Barcelona

Barcelona, Spain, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Inés García-Bouyssou, PT, MsC

Role: CONTACT

Xabier Urra, MD, PhD

Role: CONTACT

+34932275414

Facility Contacts

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Inés García-Bouyssou, PT, MsC

Role: primary

+34665538737

Other Identifiers

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HCB/2022/1193

Identifier Type: -

Identifier Source: org_study_id

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