NCT06149897

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 29, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2026

Completed
Last Updated

September 24, 2025

Status Verified

March 1, 2025

Enrollment Period

2.1 years

First QC Date

November 14, 2023

Last Update Submit

September 18, 2025

Conditions

Stroke

Keywords

tdcspost stroke fatigue

Outcome Measures

Primary Outcomes (2)

  • Fatigue Assessment Scale

    The scale consists of 10 questions about the characteristics of fatigue in the current daily routine, which are rated on a five-point range from 1, "never," to 5, "always." Higher scores indicate more fatigue, with a cut-off point of ≥24 defining the presence of fatigue.

    Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.

  • HADS

    It is a scale that can be used both at the hospital and outpatient level. It consists of 14 questions: 7 questions related to depression and another 7 related to anxiety. An independent score on each scale of ≥ 8 will be suggestive of depression and/or anxiety.

    Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.

Secondary Outcomes (6)

  • National Institute of Health Stroke Scale

    Baseline. Reported through study completion, an average of 1 year.

  • Borg Modified Scale

    During the sessions. Reported through study completion, an average of 1 year.

  • PROMIS-Sleep

    Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.

  • Modified Rankin Scale

    Baseline, 1 month post intervention and 6 months post intervention. Reported through study completion, an average of 1 year.

  • International Physical Activity Questionnaire (IPAQ)

    Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.

  • +1 more secondary outcomes

Study Arms (2)

Control group

SHAM COMPARATOR

* 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)

Device: tDCS

Experimental group

ACTIVE COMPARATOR

* 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)

Device: tDCS

Interventions

tDCSDEVICE

Non invasive brain stimulation with sham and active comparators

Also known as: physical exercise, therapeutic education
Control groupExperimental group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, Spain, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current StimulationExercise Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological TechniquesRehabilitationAftercareContinuity of Patient CarePatient CarePhysical Therapy Modalities

Central Study Contacts

Inés García-Bouyssou, PT, MsC

CONTACT

ingarcia@clinic.cat

Xabier Urra, MD, PhD

CONTACT

+34932275414xurra@clinic.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical therapist

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 29, 2023

Study Start

November 10, 2023

Primary Completion

December 5, 2025

Study Completion

February 5, 2026

Last Updated

September 24, 2025

Record last verified: 2025-03

Locations

ES(1)