tDCS Combined With Constraint-Induced Therapy in Post-Stroke Upper Limb Rehabilitation (NCT07458503) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
tDCS Combined With Constraint-Induced Therapy in Post-Stroke Upper Limb Rehabilitation
Brazil40 participantsStarted 2026-04-15
Plain-language summary
The objective of this clinical trial is to evaluate the effects of transcranial direct current stimulation (tDCS) combined with constraint-induced therapy (CIT) on upper limb motor recovery in individuals after stroke.
The main questions it aims to answer are:
Does the combination of tDCS and CIT improve upper limb motor function compared to CIT alone?
Does the combined intervention promote changes in muscle morphology and electromyographic activity?
Researchers will compare the group receiving tDCS combined with constraint-induced therapy to the group receiving constraint-induced therapy alone to determine whether the addition of cortical neuromodulation enhances motor recovery outcomes.
This is a randomized, controlled, and blinded clinical trial in which participants will be divided into two groups: one group will receive tDCS combined with CIMT, and the other will undergo only CIMT. The protocol will include 18 sessions over six weeks, three times a week.
Clinical and instrumental assessments will be performed before, during, and after the intervention, including the Fugl-Meyer scale for the upper limb, musculoskeletal ultrasound for morphological analysis, and surface electromyography for muscle activity assessment.
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* (1) present a clinical diagnosis of stroke confirmed by imaging examination and/or report issued by a neurologist; (2) are in the chronic phase of the lesion with an occurrence time greater than six months; (3) hemiparesis with brachial predominance, mild to moderate motor deficit in the affected upper limb defined by a score between 19 and 55 points on the FMA-UE; (4) have minimum joint integrity to perform the movements required in the protocol with an active range of motion of at least 20° of wrist extension, 10° of extension of the metacarpophalangeal and interphalangeal joints and 20° of elbow extension considering the standard position of 90° elbow flexion, measured with a Carci® goniometer; (5) demonstrate the ability to understand and follow simple commands on the Mini Mental State Examination (MMSE) (ANNEX II) with a score higher than 23 points for literate persons and lower than 15 points for illiterate persons.
Exclusion Criteria:(1) diagnosis of epilepsy; (2) intracranial metallic implants or implantable electronic devices; (3) contraindications to transcranial direct current stimulation (tDCS), including skin lesions on the scalp; (4) severe musculoskeletal limitations that prevent the execution of tasks; (5) history of recurrent stroke; (6) associated disabling musculoskeletal and neurological pathologies; (7) use of botulinum toxin in the previous three months; (8) uncontrolled systemic arterial hypertension or diabetes mellitus; (9) cli…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in upper limb motor function
Timeframe: Baseline and 15 days after completion of the 18-session intervention protocol.