Stroke Clinical Trial
Official title:
Optimal Therapeutic Dose of Transcranial Direct Current Stimulation for Functional Upper Limb Recovery in People With Stroke: Multicenter Randomized Clinical Trial
Stroke is one of the main causes of disability worldwide. The main disability after a stroke is hemiparesis of an Upper Limb (UL), with a prevalence of 70%. Although conventional UL therapies achieve good recovery, their effectiveness is still limited since only 5 to 20% of patients manage to completely recover. This has led to the use of therapies in a combined manner in order to achieve greater benefit. Due to its effects on brain neuroplasticity processes, transcranial direct current stimulation (tDCS), a type of non-invasive brain stimulation, has begun to be used as a complement to standard UL therapies, including combined with Constraint Induced Movement Therapy, whether original or modified (CIMT-mCIMT), with which it shares neurological principles, with evidence of its benefits. In patients with mild and moderate stroke, tDCS has been used with the aim of reestablishing the altered brain balance by reducing the hyperactivity of the unaffected hemisphere and/or activating the affected hemisphere. A recent meta-analysis mentions that tDCS plus other therapies improve the function of the UL. However, the high heterogeneity of the protocols does not allow us to know the optimal dose, which, in turn, makes decision making in clinical practice difficult. This makes it apropos to develop studies that define therapeutic doses. This would contribute to clinical guidelines and allow to optimize public resources in rehabilitation. The present study aims to compare the evolution of functional recovery of the UL in people with subacute stroke who attend the Hospital Clínico de la Universidad de Chile and the Hospital San José, after receiving bi-hemispheric tDCS, administered through a protocol of 18 thirty-minute sessions (experimental group) versus a protocol of 18 twenty-minute sessions (active comparator group). The hypothesis is that the experimental group obtains at least 5% more functional recovery compared to the active comparator group. One of the secondary objectives is to identify in which session the recovery plateau is achieved. A randomized, double-blind clinical trial is proposed, where patients will be assigned either to the experimental or active comparator group and both will receive mCIMT as standard therapy. Clinical and socio-demographic information will be gathered and patients will be evaluated with UL motor and functional recovery scales, as well as an evaluation of independence in basic Activities of Daily Living (ADL), among others.
Status | Not yet recruiting |
Enrollment | 36 |
Est. completion date | December 26, 2025 |
Est. primary completion date | November 28, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Single event of ischemic or hemorrhagic unihemispheric stroke, cortical or subcortical. - Brachial hemiparesis. - Stroke evolution time greater than 7 days and equal to or less than 90 days. - Subjects attend rehabilitation at the Hospital Clínico de la Universidad de Chile and Hospital San José. - Age equal to or greater than 18 years. - Present some level of UL motor activity: at least 20º of active wrist extension and 10º of finger extension. - Have a caregiver and/or support network if necessary to attend outpatient therapies, as well as to supervise activities at home. - Signing of informed consent by the patient. Exclusion Criteria: - Prior central stroke with motor sequelae. - Present severe aphasia with a score = 2 on the language item on the National Institutes of Health Stroke Scale evaluation. - Severe cognitive impairment, with a score = 15 points on the Mini-mental state examination. - Present shoulder subluxation and/or pain > 4 points on the visual numerical pain scale. - History of epilepsy and/or use of antiepileptic drugs. - Metal implants or pacemakers. - Pregnancy. - Any condition that, in the opinion of the doctor, impedes the correct performance of the treatment. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Chile | Agencia Nacional de Investigación y Desarrollo |
Etoom M, Hawamdeh M, Hawamdeh Z, Alwardat M, Giordani L, Bacciu S, Scarpini C, Foti C. Constraint-induced movement therapy as a rehabilitation intervention for upper extremity in stroke patients: systematic review and meta-analysis. Int J Rehabil Res. 201 — View Citation
Garrido M M, Alvarez E E, Acevedo P F, Moyano V A, Castillo N N, Cavada Ch G. Early transcranial direct current stimulation with modified constraint-induced movement therapy for motor and functional upper limb recovery in hospitalized patients with stroke — View Citation
Gomez Palacio Schjetnan A, Faraji J, Metz GA, Tatsuno M, Luczak A. Transcranial direct current stimulation in stroke rehabilitation: a review of recent advancements. Stroke Res Treat. 2013;2013:170256. doi: 10.1155/2013/170256. Epub 2013 Feb 27. — View Citation
Grefkes C, Nowak DA, Eickhoff SB, Dafotakis M, Kust J, Karbe H, Fink GR. Cortical connectivity after subcortical stroke assessed with functional magnetic resonance imaging. Ann Neurol. 2008 Feb;63(2):236-46. doi: 10.1002/ana.21228. — View Citation
Jiang L, Xu H, Yu C. Brain connectivity plasticity in the motor network after ischemic stroke. Neural Plast. 2013;2013:924192. doi: 10.1155/2013/924192. Epub 2013 Apr 24. — View Citation
Liew SL, Santarnecchi E, Buch ER, Cohen LG. Non-invasive brain stimulation in neurorehabilitation: local and distant effects for motor recovery. Front Hum Neurosci. 2014 Jun 27;8:378. doi: 10.3389/fnhum.2014.00378. eCollection 2014. — View Citation
Pollock A, Farmer SE, Brady MC, Langhorne P, Mead GE, Mehrholz J, van Wijck F. Interventions for improving upper limb function after stroke. Cochrane Database Syst Rev. 2014 Nov 12;2014(11):CD010820. doi: 10.1002/14651858.CD010820.pub2. — View Citation
Sankarasubramanian V, Machado AG, Conforto AB, Potter-Baker KA, Cunningham DA, Varnerin NM, Wang X, Sakaie K, Plow EB. Inhibition versus facilitation of contralesional motor cortices in stroke: Deriving a model to tailor brain stimulation. Clin Neurophysi — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional recovery of upper extremity | Considers the use of the upper extremity in functional activities and will be evaluated with the Wolf Motor Function Test. Minimum score=0, maximum score=75, higher scores indicating better performance. | 18 days, 3 and 6 months later | |
Secondary | Motor recovery of upper extremity | Considers global sensorimotor functioning of the upper extremity and will be evaluated with Fugl Meyer Assessment Upper Extremity. Minimum score=0, maximum score=66, higher scores indicating better performance. | 18 days, 3 and 6 months later | |
Secondary | Independence in activities of daily living | Considers improvement in functional independence and will be evaluated with Functional Independence Measure. Minimum score=18, maximum score=126, higher scores indicating better performance. | 18 days, 3 and 6 months later | |
Secondary | Quality and quantity of movement of the upper limb | Considers improvement in quality of movement and quantity of use and will be evaluated with Motor Activity Log. Minimum score=0, maximum score=5, higher scores indicating better performance. | 18 days, 3 and 6 months later | |
Secondary | Health related quality of life | Considers effect on quality of life and will be evaluated with Stroke Impact Scale. Minimum score=0, maximum score=100 for domains, higher scores indicating better performance. | 18 days, 3 and 6 months later | |
Secondary | Satisfaction with intervention | Questionnaire that allows you to know the degree of satisfaction with the intervention received. 15 questions, each one has the option to answer: strongly agree, agree, disagree, strongly disagree or neither agree nor disagree. | At the end of the treatment |
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