Ischemic StrokeCACTUSNCT07848919
Combined tDCS and Cognitive Neurorehabilitation in Post-Stroke Depression
A study testing Active transcranial direct current stimulation and Cognitive neurorehabilitation using Guttmann NeuroPersonalTrainer in people with Ischemic Stroke and Depressive Symptoms, run by Institut de Recerca Biomèdica de Lleida-Fundació Dr. Pifarré (IRBLleida) at 1 site in Spain.
Trial summary
This study evaluates a multimodal intervention pathway for affective and cognitive symptoms after ischemic stroke. Patients undergo an initial screening of depressive symptoms, cognitive function, and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke, Depressive Symptoms
- What is being tested?
- Active transcranial direct current stimulation and Cognitive neurorehabilitation using Guttmann NeuroPersonalTrainer
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteSpain
- Study dates
- 9 Apr 2024to 17 Apr 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- Acute ischemic stroke confirmed by neuroimaging
- Modified Rankin Scale (mRS) score ≤3 at discharge
- NIH Stroke Scale (NIHSS) score ≤8 at discharge
- Time from symptom onset to inclusion <15 days
- Time from ischemic stroke symptom onset to first neurological care <48 hours
Who cannot join
- Transient ischemic attack (TIA)
- Language barrier preventing adequate understanding Catalan or Spanish
- Severe pre-existing psychiatric disorder
- Active diagnosed depression at the time of stroke
- Pre-existing cognitive impairment
- Severe aphasia, defined as a score ≥2 on item 9 and/or 10 of the NIHSS
Show all 22Show fewer
- History of alcoholism or substance abuse
- Life expectancy <12 months
- History of seizures.
- Unexplained episodes of loss of consciousness potentially related to epilepsy or other cerebral disorders.
- Uncontrolled or unstable neuropsychiatric disorder.
- Implanted medical devices in the brain.
- Cardiac pacemaker.
- Electrically, mechanically, or magnetically activated implants.
- Cardiac, neural, or drug-delivery implants.
- Vascular clips.
- Severe brain lesions.
- Skin lesions at the stimulation site
- Dermatological conditions affecting the stimulation site, including dermatitis, psoriasis, or eczema.
- Frequent or severe headaches.
- Severe life-threatening medical conditions, including congestive heart failure, chronic obstructive pulmonary disease, or active malignancy.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multimodal Intervention Using Transcranial Direct Current Stimulation (tDCS) and Cognitive Neurorehabilitation to Reduce Affective Symptoms in Ischemic Stroke Patients With Mild-to-moderate Sequelae
This study evaluates a multimodal intervention pathway for affective and cognitive symptoms after ischemic stroke. Patients undergo an initial screening of depressive symptoms, cognitive function, and quality of life. Participants meeting the criteria for intervention are randomized to one of four groups: active transcranial direct current stimulation (tDCS), sham tDCS, online cognitive neurorehabilitation, or a combined intervention using active tDCS and online cognitive neurorehabilitation. Clinical outcomes include depressive symptoms, cognitive performance, and quality of life assessed longitudinally during follow-up.
Read the detailed description
Patients admitted after an acute ischaemic stroke who meet the eligibility criteria and provide written informed consent undergo an initial screening assessment including depressive symptoms, cognitive function, and perceived quality of life. Participants who meet the predefined criteria for intervention enter the randomized treatment pathway.
Participants are randomized to one of four intervention groups: active tDCS, sham tDCS, online cognitive neurorehabilitation using Guttmann NeuroPersonalTrainer (GNPT), or a multimodal intervention combining active tDCS with GNPT. Active tDCS is delivered over the dorsolateral prefrontal cortex using an anode over the left DLPFC and a cathode over the right DLPFC, at an intensity of 2 mA for 30 minutes over 14 sessions. Participants assigned to GNPT complete 32 cognitive training sessions. In the multimodal group, active tDCS is combined with GNPT during the intervention period, together with additional home-based GNPT sessions.
Participants are followed longitudinally with repeated assessments of depressive symptoms, cognitive performance, and quality of life.
- Conditions
- Ischemic Stroke, Depressive Symptoms
- Being tested
- Active transcranial direct current stimulation, Sham transcranial direct current stimulation, Cognitive neurorehabilitation using Guttmann NeuroPersonalTrainer
- Keywords
- Post-stroke depression, Transcranial direct current stimulation, tDCS, Cognitive neurorehabilitation, GNPT
- Medical subject headings
- Ischemic Stroke, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active transcranial direct current stimulationDevice
Active tDCS is delivered at 2 mA for 30 minutes over 14 sessions, with the anode positioned over the left dorsolateral prefrontal cortex (DLPFC) and the cathode over the right DLPFC.
Sham transcranial direct current stimulationDevice
Sham tDCS is delivered over 14 sessions using the same electrode montage as active tDCS, without therapeutic current stimulation.
Cognitive neurorehabilitation using Guttmann NeuroPersonalTrainerBehavioural
Participants complete 32 cognitive neurorehabilitation sessions of approximately 30 minutes each using Guttmann NeuroPersonalTrainer (GNPT). In the multimodal group, 14 GNPT sessions are performed concurrently with active tDCS and the remaining 18 sessions are completed at home.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | Participants receive 14 sessions of active transcranial direct current stimulation (tDCS). Stimulation is delivered at 2 mA for 30 minutes, with the anode positioned over the left dorsolateral prefrontal cortex (DLPFC) and the cathode over the right DLPFC. Receives: Device: Active transcranial direct current stimulation |
| Sham tDCS | Sham comparator | Participants receive 14 sessions using the same electrode montage as the active tDCS group, but with sham stimulation delivered according to the study protocol Receives: Device: Sham transcranial direct current stimulation |
| Cognitive Neurorehabilitation | Experimental | Participants complete 32 online cognitive neurorehabilitation sessions of 30 minutes using Guttmann NeuroPersonalTrainer (GNPT). Receives: Behavioral: Cognitive neurorehabilitation using Guttmann NeuroPersonalTrainer |
| Multimodal Intervention | Experimental | Participants receive 14 sessions of active tDCS combined with cognitive neurorehabilitation using GNPT. The remaining 18 GNPT sessions are completed at home, for a total of 32 cognitive training sessions. Receives: Device: Active transcranial direct current stimulation; Behavioral: Cognitive neurorehabilitation using Guttmann NeuroPersonalTrainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptoms measured with the 17-item Hamilton Depression Rating Scale (HDRS-17)
Depressive symptoms are assessed using the 17-item Hamilton Depression Rating Scale (HDRS-17) at the pre-intervention assessment (T1), 3 months post-randomization (T2), and 6 months post-randomization (T3). Total scores range from 0 to 52, with higher scores indicating greater severity of depressive symptoms. In this study, a score ≥7 was considered indicative of affective impairment.
Measured: From initial screening through the 6-month follow-up period
Secondary outcomes (2)
Change in cognitive composite z-score
Cognitive performance is assessed at the pre-intervention assessment (T1), 3 months post-randomization (T2), and 6 months post-randomization (T3). Raw neuropsychological test scores are converted into scaled scores using standardized population-based norms and subsequently transformed into z-scores. Domain-specific cognitive scores are calculated by averaging the z-scores of tests assigned to each cognitive domain. The global cognitive composite is calculated as the average z-score across all individual tests included in the neuropsychological battery. The composite z-score has no fixed minimum or maximum value; a score of 0 represents the normative mean and one z-score unit represents one standard deviation. Higher scores indicate better cognitive performance.
Measured: From randomization through the 6-month follow-up
Change in perceived quality of life measured with the ECVI-38
Perceived quality of life is assessed using the Stroke-Specific Quality of Life Scale (ECVI-38) at the pre-intervention assessment (T1), 3 months post-randomization (T2), and 6 months post-randomization (T3). The ECVI-38 is a 38-item stroke-specific measure. Each item is scored from 1 to 5, yielding a total score ranging from 38 to 190. Higher scores indicate poorer health-related quality of life.
Measured: From randomization through the 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start9 Apr 2024
- Primary completion17 Apr 2026
- Study completion17 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recerca Biomèdica de Lleida-Fundació Dr. Pifarré (IRBLleida)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848919
- Sponsor's protocol ID
- CEIC-2799
- Acronym
- CACTUS
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Intervention Using Transcranial Direct Current Stimulation (tDCS) and Cognitive Neurorehabilitation to Reduce Affective Symptoms in Ischemic Stroke Patients With Mild-to-moderate Sequelae
- ClinicalTrials.gov ID
- NCT07848919
- Acronym / sponsor ID
- CACTUS / CEIC-2799
- Conditions
- Ischemic Stroke, Depressive Symptoms
- Keywords
- Post-stroke depression, Transcranial direct current stimulation, tDCS, Cognitive neurorehabilitation, GNPT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Institut de Recerca Biomèdica de Lleida-Fundació Dr. Pifarré (IRBLleida)University, hospital or other
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 17 Apr 2026 (actual)
- Study completion
- 17 Apr 2026 (actual)
- First posted
- 30 Sep 2026 (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 evaluates a multimodal intervention pathway for affective and cognitive symptoms after ischemic stroke. Patients undergo an initial screening of depressive symptoms, cognitive function, and quality of life. Participants meeting the criteria for intervention are randomized to one of four groups: active transcranial direct current stimulation (tDCS), sham tDCS, online cognitive neurorehabilitation, or a combined intervention using active tDCS and online cognitive neurorehabilitation. Clinical outcomes include depressive symptoms, cognitive performance, and quality of life assessed longitudinally during follow-up.
Detailed description
Patients admitted after an acute ischaemic stroke who meet the eligibility criteria and provide written informed consent undergo an initial screening assessment including depressive symptoms, cognitive function, and perceived quality of life. Participants who meet the predefined criteria for intervention enter the randomized treatment pathway.
Participants are randomized to one of four intervention groups: active tDCS, sham tDCS, online cognitive neurorehabilitation using Guttmann NeuroPersonalTrainer (GNPT), or a multimodal intervention combining active tDCS with GNPT. Active tDCS is delivered over the dorsolateral prefrontal cortex using an anode over the left DLPFC and a cathode over the right DLPFC, at an intensity of 2 mA for 30 minutes over 14 sessions. Participants assigned to GNPT complete 32 cognitive training sessions. In the multimodal group, active tDCS is combined with GNPT during the intervention period, together with additional home-based GNPT sessions.
Participants are followed longitudinally with repeated assessments of depressive symptoms, cognitive performance, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Active transcranial direct current stimulationParticipants receive 14 sessions of active transcranial direct current stimulation (tDCS). Stimulation is delivered at 2 mA for 30 minutes, with the anode positioned over the left dorsolateral prefrontal cortex (DLPFC) and the cathode over the right DLPFC. |
| Sham tDCS | Sham comparator | Device: Sham transcranial direct current stimulationParticipants receive 14 sessions using the same electrode montage as the active tDCS group, but with sham stimulation delivered according to the study protocol |
| Cognitive Neurorehabilitation | Experimental | Behavioral: Cognitive neurorehabilitation using Guttmann NeuroPersonalTrainerParticipants complete 32 online cognitive neurorehabilitation sessions of 30 minutes using Guttmann NeuroPersonalTrainer (GNPT). |
| Multimodal Intervention | Experimental | Device: Active transcranial direct current stimulation, Behavioral: Cognitive neurorehabilitation using Guttmann NeuroPersonalTrainerParticipants receive 14 sessions of active tDCS combined with cognitive neurorehabilitation using GNPT. The remaining 18 GNPT sessions are completed at home, for a total of 32 cognitive training sessions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-80 years
- Acute ischemic stroke confirmed by neuroimaging
- Modified Rankin Scale (mRS) score ≤3 at discharge
- NIH Stroke Scale (NIHSS) score ≤8 at discharge
- Time from symptom onset to inclusion <15 days
Key exclusion criteria (22 listed)
- Transient ischemic attack (TIA)
- Language barrier preventing adequate understanding Catalan or Spanish
- Severe pre-existing psychiatric disorder
- Active diagnosed depression at the time of stroke
- Pre-existing cognitive impairment
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 |
|---|---|---|
| Active transcranial direct current stimulationActive tDCS is delivered at 2 mA for 30 minutes over 14 sessions, with the anode positioned over the left dorsolateral prefrontal cortex (DLPFC) and the cathode over the right DLPFC. | Device | Active tDCS, Multimodal Intervention |
| Sham transcranial direct current stimulationSham tDCS is delivered over 14 sessions using the same electrode montage as active tDCS, without therapeutic current stimulation. | Device | Sham tDCS |
| Cognitive neurorehabilitation using Guttmann NeuroPersonalTrainerParticipants complete 32 cognitive neurorehabilitation sessions of approximately 30 minutes each using Guttmann NeuroPersonalTrainer (GNPT). In the multimodal group, 14 GNPT sessions are performed concurrently with active tDCS and the remaining 18 sessions are completed at home. | Behavioural | Cognitive Neurorehabilitation, Multimodal Intervention |
Primary outcome
Change in depressive symptoms measured with the 17-item Hamilton Depression Rating Scale (HDRS-17)
Time frame: From initial screening through the 6-month follow-up period
Depressive symptoms are assessed using the 17-item Hamilton Depression Rating Scale (HDRS-17) at the pre-intervention assessment (T1), 3 months post-randomization (T2), and 6 months post-randomization (T3). Total scores range from 0 to 52, with higher scores indicating greater severity of depressive symptoms. In this study, a score ≥7 was considered indicative of affective impairment.
2 secondary outcomes
Change in cognitive composite z-score
Time frame: From randomization through the 6-month follow-up
Change in perceived quality of life measured with the ECVI-38
Time frame: From randomization through the 6-month follow-up
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 30 Sep 2026.
- Individual participant dataSharing planned: No
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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 Active transcranial direct current stimulation and Cognitive neurorehabilitation using Guttmann NeuroPersonalTrainer in people with Ischemic Stroke and Depressive Symptoms, run by Institut de Recerca Biomèdica de Lleida-Fundació Dr. Pifarré (IRBLleida) 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 6 inclusion and 22 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 30 Sep 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?
Change in depressive symptoms measured with the 17-item Hamilton Depression Rating Scale (HDRS-17) (time frame: From initial screening through the 6-month follow-up period). 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 30 Sep 2026.