Clinical trial NCT06149897: Feasibility and Effectiveness of tDCS in the Treatment of Post-stroke Fatigue (EFECTS).
Official title: Feasibility and Effectiveness of Tdcs in a Multimodal Treatment With Health Education and Aerobic Exercise in the Treatment of Post-stroke Fatigue.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: tdcs
post stroke fatigue
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fatigue Assessment Scale
timeFrame: Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.
measure: HADS
timeFrame: Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.
Secondary outcomes:
measure: National Institute of Health Stroke Scale
timeFrame: Baseline. Reported through study completion, an average of 1 year.
measure: Borg Modified Scale
timeFrame: During the sessions. Reported through study completion, an average of 1 year.
measure: PROMIS-Sleep
timeFrame: Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.
measure: Modified Rankin Scale
timeFrame: Baseline, 1 month post intervention and 6 months post intervention. Reported through study completion, an average of 1 year.
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.
measure: Eq-5D
timeFrame: Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
References: