Optimal Therapeutic Dose of tDCS for Functional Upper Limb Recovery in People With Stroke

NCT06396715 | Not Yet Recruiting DMC

• 1 other identifier: OAIC: 1390/23
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stroke; Neurologic Deficits

Keywords

Stroke; Transcranial direct current stimulation; Upper limb; Occupational Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Motor recovery of upper extremity

  18 days, 3 and 6 months later

• Independence in activities of daily living

  18 days, 3 and 6 months later

• Quality and quantity of movement of the upper limb

  18 days, 3 and 6 months later

• Health related quality of life

  18 days, 3 and 6 months later

• Satisfaction with intervention

  At the end of the treatment

Study Arms (2)

30-minute tDCS with mCIMT

EXPERIMENTAL

tDCS: the tDCS montage will be of a bi-hemispheric and the stimulation will be applied simultaneously to the upper extremity motor training session carried out in the hospital. There will be a total of 18 sessions with 30 minutes of tDCS stimulation (2 mA intensity), with a frequency of three times a week for six weeks. mCIMT: during a period of five days a week, for six weeks, both groups will perform a mCIMT protocol. On days when the patient does not go to the hospital for treatment, they must perform the activities at home with the support of a family member or caregiver if necessary. 1. Restriction of movements of the unaffected hand through the use of a glove for 6 hours per day: the glove limits the mobility of the fingers but allows free movement of the wrist, elbow and shoulder. 2. Intensive and individualized training of the affected arm for 2 hours a day.

Device: Transcranial direct current stimulation

20-minute tDCS with mCIMT

ACTIVE COMPARATOR

tDCS: the tDCS montage will be of a bi-hemispheric and the stimulation will be applied simultaneously to the upper extremity motor training session carried out in the hospital. There will be a total of 18 sessions with 20 minutes of tDCS stimulation (2 mA intensity), with a frequency of three times a week for six weeks. mCIMT: during a period of five days a week, for six weeks, both groups will perform a mCIMT protocol. On days when the patient does not go to the hospital for treatment, they must perform the activities at home with the support of a family member or caregiver if necessary. 1. Restriction of movements of the unaffected hand through the use of a glove for 6 hours per day: the glove limits the mobility of the fingers but allows free movement of the wrist, elbow and shoulder. 2. Intensive and individualized training of the affected arm for 2 hours a day.

Device: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulation DEVICE

tDCS is a type of non-invasive brain stimulation that in a standard paradigm, low intensity current (1-2 mA) is applied continuously through a battery connected to two 20 to 35 cm2 surface electrodes located on the scalp: an anode and a cathode. In the interhemispheric competition model, tDCS can serve as a means to increase ipsilesional cortical excitability through anodal stimulation, to decrease contralesional cortical excitability through cathodal stimulation, or to do both through a montage of bi-hemispheric electrodes.

20-minute tDCS with mCIMT; 30-minute tDCS with mCIMT

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chile: lead
• Agencia Nacional de Investigación y Desarrollo: collaborator

Related Publications (8)

• 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.

  PMID: 25387001 RESULT

• 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: A randomized, multicentre, double-blind, clinical trial. Brain Stimul. 2023 Jan-Feb;16(1):40-47. doi: 10.1016/j.brs.2022.12.008. Epub 2022 Dec 28.

  PMID: 36584748 RESULT

• 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.

  PMID: 23738150 RESULT

• 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.

  PMID: 17896791 RESULT

• 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 Neurophysiol. 2017 Jun;128(6):892-902. doi: 10.1016/j.clinph.2017.03.030. Epub 2017 Mar 21.

  PMID: 28402865 RESULT

• 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. 2016 Sep;39(3):197-210. doi: 10.1097/MRR.0000000000000169.

  PMID: 27123790 RESULT

• 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.

  PMID: 25018714 RESULT

• 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.

  PMID: 23533955 RESULT

MeSH Terms

Conditions

Stroke; Neurologic Manifestations

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Maricel Garrido

  University of Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maricel Garrido

CONTACT

+56229788038; mgarridom@hcuch.cl

Nicole Jara

CONTACT

+56229788040; njarag@hcuch.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients will be assigned to the 30-minute tDCS with mCIMT or 20-minute tDCS with mCIMT group using block randomization. When the informed consent is signed by the patient, the recruiter will notify the person in charge of randomization (the one who has no relationship with the patient or their medical data) to assign the patient to one of the two groups (called group 1) or group 2), without knowing which corresponds to 30 or 20 minutes of stimulation. Once the group is known, the therapy coordinator will be informed, and make a note of the assigned group (1 or 2) on the patient's record sheet. The patient, the therapists and the evaluators will be kept blinded since they will not know the duration of the stimulation of group 1 or 2.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: This methodological design is carried out following the guidelines of the CONSORT 2010 guidelines for clinical trials. Study type and design: a two-arm, multicenter, double-blind randomized clinical trial (RCT) is proposed. Population: adults with a diagnosis of subacute unihemispheric stroke with motor and functional deficit of the upper limb who attend the Hospital Clínico de la Universidad de Chile (HCUCH) and the Hospital San José (HSJ).

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 2, 2024
• Study Start: May 1, 2024
• Primary Completion: November 28, 2025
• Study Completion: December 26, 2025
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: For a year.
• Access Criteria: Send email to main researcher.