Effect of tDCS Timing on Motor Recovery in Acute Stroke Rehabilitation

NCT07331779 | Not Yet Recruiting

• 1 other identifier: 45.482.838
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized, double-blind, sham-controlled clinical trial investigates how the timing of transcranial direct current stimulation (tDCS) influences functional recovery during acute stroke rehabilitation. Sixty hospitalized patients with confirmed acute stroke will be randomly assigned to one of three groups. Each day, all participants will receive three tDCS sessions: one before, one during, and one after their rehabilitation session. In each group, only one of these three daily stimulations is active, while the other two are sham, allowing a direct comparison of timing effects while maintaining blinding. All participants will complete five consecutive days of conventional rehabilitation combined with the tDCS protocol. Functional, sensory, psychological, and motor outcomes will be assessed at baseline and at the end of the intervention week. The study aims to determine whether the timing of tDCS application influences early post-stroke recovery and to inform the design of future confirmatory trials.

Conditions

Acute Stroke

Outcome Measures

Primary Outcomes (1)

• Change in upper limb motor function (Wolf Motor Function Test, WMFT)

  The WMFT assesses upper limb motor function using timed and functional tasks. The primary outcome is the change in WMFT performance (time and/or functional score) between baseline and Day 5, comparing the three timing conditions of active tDCS (before, during, after rehabilitation). The Wolf Motor Function Test (WMFT) will be used to assess upper-limb motor performance. The Functional Ability Scale ranges from 0 to 5, with higher scores indicating better functional movement quality. Performance Time is measured from 0 to 120 seconds, with lower times indicating better performance.

  Baseline (Day 1, pre-intervention) to end of intervention (Day 5, post-intervention).

Secondary Outcomes (7)

• Change in sensory function (Semmes-Weinstein Monofilament Test, SWMT)

  Baseline (Day 1) to Day 5.

• Change in spasticity (Tardieu Scale)

  Baseline (Day 1) to Day 5.

• Change in functional independence (Barthel Index)

  Baseline (Day 1) to Day 5.

• Change in balance and gait (Tinetti Performance-Oriented Mobility Assessment)

  Baseline (Day 1) to Day 5.

• Change in health-related quality of life after stroke (Stroke Impact Scale, SIS)

  Baseline (Day 1) to Day 5.

Study Arms (3)

Arm 1 - Active tDCS Before Rehabilitation

EXPERIMENTAL

Active tDCS Before Rehabilitation

Device: tDCS; Device: Sham Transcranial Direct Current Stimulation (Sham tDCS)

Arm 2 - Active tDCS During Rehabilitation

EXPERIMENTAL

Active tDCS During Rehabilitation

Device: tDCS; Device: Sham Transcranial Direct Current Stimulation (Sham tDCS)

Arm 3 - Active tDCS After Rehabilitation

EXPERIMENTAL

Active tDCS After Rehabilitation

Device: tDCS; Device: Sham Transcranial Direct Current Stimulation (Sham tDCS)

Interventions

tDCS DEVICE

Transcranial Direct Current Stimulation (tDCS) is delivered using a non-invasive electrical stimulation device that applies a low-intensity direct current (2 mA) through two saline-soaked sponge electrodes placed on the scalp. Each participant receives three stimulation sessions per day: one before, one during, and one after their rehabilitation session. In each randomized group, only one of these three daily stimulations is active, while the other two are sham (brief ramp-up and ramp-down without sustained current). The active stimulation lasts 20 minutes. Sham sessions mimic the initial sensations of stimulation to maintain blinding. Electrode placement is standardized according to the lesioned hemisphere. All participants receive five consecutive days of this combined protocol alongside their usual rehabilitation program.

Also known as: Rehabilitation

Arm 1 - Active tDCS Before Rehabilitation; Arm 2 - Active tDCS During Rehabilitation; Arm 3 - Active tDCS After Rehabilitation

Sham Transcranial Direct Current Stimulation (Sham tDCS) DEVICE

Sham tDCS is delivered using the same device and electrode placement as active stimulation, but without administering a sustained electrical current. The device applies a brief ramp-up and ramp-down of current at the beginning and end of the session to mimic the initial sensations of active tDCS (e.g., tingling or warmth), after which no current is delivered. Each participant receives three tDCS sessions per day (before, during, and after rehabilitation), but only one is active; the other two are sham. Sham stimulation is used to maintain double-blinding and ensure that participants and assessors cannot distinguish between active and inactive sessions.

Arm 1 - Active tDCS Before Rehabilitation; Arm 2 - Active tDCS During Rehabilitation; Arm 3 - Active tDCS After Rehabilitation

Eligibility Criteria

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

You may qualify if:

• Hospitalization for stroke rehabilitation Hospitalized in a stroke rehabilitation unit at CHU de Liège.
• Confirmed acute stroke Diagnosis of acute stroke (ischemic or hemorrhagic) confirmed by neuroimaging, according to local clinical practice.
• Time since stroke In the acute/subacute phase, as defined in the protocol (e.g., within X days/weeks after stroke onset) - to be specified exactly as in your protocol.
• Age Age ≥ 18 years.
• Capacity to consent Able to understand the study information and provide written informed consent.
• Motor impairment of the upper limb Presence of motor deficit of the upper limb on the affected side, sufficient to perform the WMFT tasks (according to protocol thresholds, if specified).
• Medically stable Clinically stable and judged by the treating physician as able to participate in daily rehabilitation and tDCS sessions.

You may not qualify if:

• Contraindications to tDCS or cranial stimulation
• Implanted electronic devices in the head or neck (e.g., deep brain stimulator, cochlear implant, implanted neurostimulator, pacemaker with leads near the head).
• Metal implants in the skull (excluding dental fillings) in the area of stimulation.
• Large skull defect or craniectomy over the stimulation site.
• History of seizures History of epilepsy or unprovoked seizures not adequately controlled, if considered a contraindication to tDCS by the investigator.
• Severe cognitive or communication impairment Severe cognitive impairment, aphasia, or comprehension difficulties preventing understanding of the study or execution of the tasks, as judged by the investigator.
• Severe comorbidities Unstable medical conditions (e.g., uncontrolled cardiac, respiratory, metabolic, or systemic disease) that could interfere with participation or increase risk.
• Severe psychiatric disorder Current severe psychiatric illness (e.g., psychosis, severe untreated major depression) that may affect cooperation or safety, as judged by the investigator.
• Skin conditions at electrode sites Skin lesions, infections, severe dermatitis, or wounds at or near the planned electrode placement sites.
• Concurrent participation in another interventional trial Participation in another interventional clinical trial that could interfere with the outcomes or safety of this study.
• Pregnancy Pregnancy or breastfeeding, if considered a contraindication according to local tDCS safety policy (optional, depending on your protocol stance).
• Any other reason Any condition or circumstance that, in the opinion of the investigator, makes the patient unsuitable for the study or unable to comply with the protocol.

Sponsors & Collaborators

• University of Liege: lead

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation; Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Stephen Bornheim, PhD, PT

CONTACT

003243233843; stephen.bornheim@uliege.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 12, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share