Acute StrokeNCT07331779
Effect of tDCS Timing on Motor Recovery in Acute Stroke Rehabilitation
A study testing tDCS in people with Acute Stroke, run by University of Liege.
Trial 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. 198 hospitalized patients with confirmed acute stroke will be randomly assigned to one of three groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute 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
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Timing Matters: Comparing Pre , Peri , and Post Rehabilitation tDCS in Acute Stroke Recovery
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. 198 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 2 sets of five consecutive days of conventional rehabilitation combined with the tDCS protocol (2 weeks). 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
- Being tested
- tDCS, Sham Transcranial Direct Current Stimulation (Sham tDCS)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Also called Rehabilitation
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 2 sets of five consecutive days (2 weeks) of this combined protocol alongside their usual rehabilitation program.
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Active tDCS Before Rehabilitation | Experimental | Active tDCS Before Rehabilitation Receives: Device: tDCS; Device: Sham Transcranial Direct Current Stimulation (Sham tDCS) |
| Arm 2 - Active tDCS During Rehabilitation | Experimental | Active tDCS During Rehabilitation Receives: Device: tDCS; Device: Sham Transcranial Direct Current Stimulation (Sham tDCS) |
| Arm 3 - Active tDCS After Rehabilitation | Experimental | Active tDCS After Rehabilitation Receives: Device: tDCS; Device: Sham Transcranial Direct Current Stimulation (Sham tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The SWMT evaluates cutaneous sensory thresholds using calibrated monofilaments. The outcome is the change in sensory detection thresholds between baseline and Day 5.
The Semmes-Weinstein Monofilament Test will be used to assess cutaneous pressure sensitivity. Monofilaments range from approximately 0.008 g to 300 g. Lower detectable force values indicate better tactile sensitivity, whereas higher detectable force values indicate worse sensory function.
Measured: Baseline (Day 1) to Day 5.
Change in spasticity (Tardieu Scale)
The Tardieu Scale assesses spasticity by measuring muscle reaction to passive stretch at different velocities. The outcome is the change in Tardieu scores (e.g., angle of catch, quality of muscle reaction) between baseline and Day 5.
The Tardieu Spasticity Scale will be used to assess spasticity. It includes two components: (1) the Quality of Muscle Reaction score (0-4, where higher scores indicate worse spasticity), and (2) the Angle of Muscle Reaction, measured in degrees from 0° to the joint's full passive range, where higher values indicate a better outcome.
Measured: Baseline (Day 1) to Day 5.
Change in functional independence (Barthel Index)
The Barthel Index measures independence in activities of daily living. The outcome is the change in total Barthel score between baseline and Day 5.
"The Barthel Index of Activities of Daily Living will be used to assess functional independence. Scores range from 0 to 100, with higher scores indicating better independence and lower scores indicating greater dependency.
Measured: Baseline (Day 1) to Day 5.
Change in balance and gait (Tinetti Performance-Oriented Mobility Assessment)
The Tinetti test evaluates balance and gait performance and estimates fall risk. The outcome is the change in Tinetti total score between baseline and Day 5.
The Tinetti Assessment Tool (Performance-Oriented Mobility Assessment) will be used to evaluate balance and gait. The Balance Subscale ranges from 0 to 16 and the Gait Subscale from 0 to 12. The total score ranges from 0 to 28. In all cases, higher scores indicate better performance and lower fall risk.
Measured: Baseline (Day 1) to Day 5.
Change in health-related quality of life after stroke (Stroke Impact Scale, SIS)
The Stroke Impact Scale is a patient-reported questionnaire assessing multiple domains affected by stroke (e.g., physical function, emotion, participation). The outcome is the change in SIS scores between baseline and Day 5.
The Stroke Impact Scale (Version 3.0) will be used to assess patient-reported impact of stroke across multiple functional domains. Items are scored from 1 to 5, with higher scores indicating better perceived function. Domain scores are transformed to a 0-100 scale, where higher values indicate better outcomes.
Measured: Baseline (Day 1) to Day 5.
Change in anxiety and depression (Hospital Anxiety and Depression Scale, HADS)
The HADS evaluates symptoms of anxiety and depression using a 14-item questionnaire. The outcome is the change in anxiety and depression subscale scores between baseline and Day 5.
"The Hospital Anxiety and Depression Scale will be used to assess symptoms of anxiety and depression. Each subscale ranges from 0 to 21, with higher scores indicating worse symptoms. The optional total score ranges from 0 to 42, with higher values indicating greater emotional distress.
Measured: Baseline (Day 1) to Day 5.
Incidence of adverse events and tolerability of tDCS
Number, type, and severity of adverse events potentially related to tDCS (e.g., headache, skin irritation, discomfort, dizziness) recorded at each session using standardized questioning and observation.
Measured: Throughout the 5 days of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bornheim Stephen, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331779
- Sponsor's protocol ID
- 45.482.838
- Status last verified
- Jun 2026
- First submitted
- 26 Dec 2025
- Last updated
- 2 Jul 2026
- Results posted
- 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 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing Matters: Comparing Pre , Peri , and Post Rehabilitation tDCS in Acute Stroke Recovery
- ClinicalTrials.gov ID
- NCT07331779
- Acronym / sponsor ID
- 45.482.838
- Conditions
- Acute Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 12 Jan 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 randomized, double-blind, sham-controlled clinical trial investigates how the timing of transcranial direct current stimulation (tDCS) influences functional recovery during acute stroke rehabilitation. 198 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 2 sets of five consecutive days of conventional rehabilitation combined with the tDCS protocol (2 weeks). 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Active tDCS Before Rehabilitation | Experimental | Device: tDCS, Device: Sham Transcranial Direct Current Stimulation (Sham tDCS)Active tDCS Before Rehabilitation |
| Arm 2 - Active tDCS During Rehabilitation | Experimental | Device: tDCS, Device: Sham Transcranial Direct Current Stimulation (Sham tDCS)Active tDCS During Rehabilitation |
| Arm 3 - Active tDCS After Rehabilitation | Experimental | Device: tDCS, Device: Sham Transcranial Direct Current Stimulation (Sham tDCS)Active tDCS After Rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
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: RehabilitationTranscranial 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 2 sets of five consecutive days (2 weeks) of this combined protocol alongside their usual rehabilitation program. | Device | 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)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. | Device | Arm 1 - Active tDCS Before Rehabilitation, Arm 2 - Active tDCS During Rehabilitation, Arm 3 - Active tDCS After Rehabilitation |
Primary outcome
Change in upper limb motor function (Wolf Motor Function Test, WMFT)
Time frame: Baseline (Day 1, pre-intervention) to end of intervention (Day 5, post-intervention).
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.
7 secondary outcomes
Change in sensory function (Semmes-Weinstein Monofilament Test, SWMT)
Time frame: Baseline (Day 1) to Day 5.
Change in spasticity (Tardieu Scale)
Time frame: Baseline (Day 1) to Day 5.
Change in functional independence (Barthel Index)
Time frame: Baseline (Day 1) to Day 5.
Change in balance and gait (Tinetti Performance-Oriented Mobility Assessment)
Time frame: Baseline (Day 1) to Day 5.
Change in health-related quality of life after stroke (Stroke Impact Scale, SIS)
Time frame: Baseline (Day 1) to Day 5.
Change in anxiety and depression (Hospital Anxiety and Depression Scale, HADS)
Time frame: Baseline (Day 1) to Day 5.
Incidence of adverse events and tolerability of tDCS
Time frame: Throughout the 5 days of intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 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.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Acute Stroke, run by University of Liege.
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 7 inclusion and 12 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: opening soon, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen Bornheim, PhD, PT (003243233843, stephen.bornheim@uliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in upper limb motor function (Wolf Motor Function Test, WMFT) (time frame: Baseline (Day 1, pre-intervention) to end of intervention (Day 5, post-intervention).). 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 2 Jul 2026.