Combined tDCS and Cognitive Neurorehabilitation in Post-Stroke Depression

NCT07848919 | Completed

• 1 other identifier: CEIC-2799
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Ischemic Stroke; Depressive Symptoms

Keywords

Post-stroke depression; Transcranial direct current stimulation; tDCS; Cognitive neurorehabilitation; GNPT

Outcome Measures

Primary Outcomes (1)

• 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.

  From initial screening through the 6-month follow-up period

Secondary Outcomes (2)

• Change in cognitive composite z-score

  From randomization through the 6-month follow-up

• Change in perceived quality of life measured with the ECVI-38

  From randomization through the 6-month follow-up

Study Arms (4)

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.

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

Device: Sham transcranial direct current stimulation

Cognitive Neurorehabilitation

EXPERIMENTAL

Participants complete 32 online cognitive neurorehabilitation sessions of 30 minutes using Guttmann NeuroPersonalTrainer (GNPT).

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.

Device: Active transcranial direct current stimulation; Behavioral: Cognitive neurorehabilitation using Guttmann NeuroPersonalTrainer

Interventions

Active transcranial direct current stimulation DEVICE

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.

Active tDCS; Multimodal Intervention

Sham transcranial direct current stimulation DEVICE

Sham tDCS is delivered over 14 sessions using the same electrode montage as active tDCS, without therapeutic current stimulation.

Sham tDCS

Cognitive neurorehabilitation using Guttmann NeuroPersonalTrainer BEHAVIORAL

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.

Cognitive Neurorehabilitation; Multimodal Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ischemic stroke symptom onset to first neurological care \<48 hours

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Institut de Recerca Biomèdica de Lleida-Fundació Dr. Pifarré (IRBLleida): lead

Study Sites (1)

Hospital Universitari Arnau de Vilanova

Lleida, Lleida, 25198, Spain

Location

MeSH Terms

Conditions

Ischemic Stroke; Depression

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 30, 2026
• Study Start: April 9, 2024
• Primary Completion: April 17, 2026
• Study Completion: April 17, 2026
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)