Effect of tDCS Timing on Motor Recovery in Acute Stroke Rehabilitation
ConditionAcute Stroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Liege
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Hospitalization for stroke rehabilitation Hospitalized in a stroke rehabilitation unit at CHU de Liège.
Disqualifiers
Contraindications to tDCS or cranial stimulation
Trial design
Design model
Parallel
Treatments tested in this trial
tDCS
DeviceTranscranial 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)
DeviceSham 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.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Arm 1 - Active tDCS Before RehabilitationExperimental treatment 2 interventions
Group B: Arm 2 - Active tDCS During RehabilitationExperimental treatment 2 interventions
Group C: Arm 3 - Active tDCS After RehabilitationExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
Baseline (Day 1, pre-intervention) to end of intervention (Day 5, post-intervention).Secondary outcomes
1
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.
Time frame
Baseline (Day 1) to Day 5.2
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.
Time frame
Baseline (Day 1) to Day 5.3
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.
Time frame
Baseline (Day 1) to Day 5.4
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.
Time frame
Baseline (Day 1) to Day 5.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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