StrokeEFECTSNCT06149897
Feasibility and Effectiveness of tDCS in the Treatment of Post-stroke Fatigue (EFECTS).
A study testing tDCS in people with Stroke, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
This study aims to analyze the use of non-invasive brain stimulation (tDCS) is beneficial for the treatment of post-stroke fatigue. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- 10 Nov 2023to 21 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Effectiveness of Tdcs in a Multimodal Treatment With Health Education and Aerobic Exercise in the Treatment of Post-stroke Fatigue.
This study aims to analyze the use of non-invasive brain stimulation (tDCS) is beneficial for the treatment of post-stroke fatigue.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Also called physical exercise, therapeutic education
Non invasive brain stimulation with sham and active comparators
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
It is a scale with 15 items that is used to measure the severity of stroke. It includes different areas: level of consciousness, eye movements, integrity of visual fields, facial movements, muscle strength, sensitivity, coordination, language and negligence. Each item is scored on an ordinal scale from 0 to 2, 0 to 3 or 0 to 4. The total is added and a score is obtained that can range from 0 to 42, the higher the score, the greater the deficits.
Measured: Baseline. Reported through study completion, an average of 1 year.
Borg Modified Scale
The Borg scale is a tool that measures a person's perception of exertion, shortness of breath, and fatigue during physical exertion. It is a modified scale, it is an 11-point scale that ranges from 0=no fatigue to 10=very great effort.
Measured: During the sessions. Reported through study completion, an average of 1 year.
PROMIS-Sleep
This is a Likert-type scale that evaluates the quality of sleep during the last week. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
Measured: Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.
Modified Rankin Scale
It is the most commonly used functional measure in stroke research, particularly in studies evaluating the effectiveness of treatments. The scale is numerical and ranges from 0 to 6. 0: no symptoms; 1: without significant disability (the patient is able to carry out his/her usual activities and obligations); 2: mild disability; 3: moderate disability; 4: moderately severe disability; 5: severe disability (totally dependent patient); 6: death.
Measured: Baseline, 1 month post intervention and 6 months post intervention. Reported through study completion, an average of 1 year.
International Physical Activity Questionnaire (IPAQ)
To measure the level of physical activity during the last week. There are two forms of output from scoring the IPAQ. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity. A MET is a multiple of your estimated resting energy expenditure. One MET is what you expend when you are at rest. Therefore 2 METS is twice what you expend at rest. To get a continuous variable score from the IPAQ (MET minutes a week) we will consider walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS.
Measured: Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.
Eq-5D
Assess the quality of life perceived by the patients. The scale ranges from 100 ('the best imaginable health state' or 'the best health state you can imagine') to 0 ('the worst imaginable health state' or 'the worst health you can imagine'). This is used to obtain a respondent's stated preference values, not to record their own health state.
Measured: Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start10 Nov 2023
- Primary completion5 May 2026
- Study completion21 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inés García Bouyssou, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149897
- Sponsor's protocol ID
- HCB/2022/1193
- Acronym
- EFECTS
- Status last verified
- May 2026
- First submitted
- 14 Nov 2023
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of Tdcs in a Multimodal Treatment With Health Education and Aerobic Exercise in the Treatment of Post-stroke Fatigue.
- ClinicalTrials.gov ID
- NCT06149897
- Acronym / sponsor ID
- EFECTS / HCB/2022/1193
- Conditions
- Stroke
- Keywords
- tdcs, post stroke fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 21 May 2026 (actual)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Device: tDCS* 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) |
| Experimental group | Active comparator | Device: tDCS* 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) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSAlso: physical exercise, therapeutic educationNon invasive brain stimulation with sham and active comparators | Device | Control group, Experimental group |
Primary outcome
Fatigue Assessment Scale
Time frame: Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.
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.
HADS
Time frame: Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.
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.
6 secondary outcomes
National Institute of Health Stroke Scale
Time frame: Baseline. Reported through study completion, an average of 1 year.
Borg Modified Scale
Time frame: During the sessions. Reported through study completion, an average of 1 year.
PROMIS-Sleep
Time frame: Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.
Modified Rankin Scale
Time frame: Baseline, 1 month post intervention and 6 months post intervention. Reported through study completion, an average of 1 year.
International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.
Eq-5D
Time frame: Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Stroke, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Assessment Scale (time frame: Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.