An interventional study of Transcranial direct current stimulation in Stroke and Neurologic Deficits, sponsored by University of Chile. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-02.
Sponsored by University of Chile · Not applicable, Interventional, and Treatment
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.
Motor deficit and disability of the upper extremity (US) continues to be the most common sequelae in these patients, which has a significant impact on daily activities. It reduces independence and the probability of returning to work, among others. Although there is a high number of treatments with evidence, patients continue to have sequelae deficits. In addition to this, the high heterogeneity of the protocols makes it difficult to select the best alternative. Therefore, when deciding to use a treatment one of the biggest questions is to determine which combination of therapies and which dose is the most effective.
In the clinical trial carried out by our research team and published in 2022, it was demonstrated that the combination of rehabilitation strategies such as modified Constraint Induced Movement Therapy (mCIMT) and Transcranial Direct Current Stimulation (tDCS), generate significant results in motor and functional recovery of Ul in patients with acute and subacute stroke who are hospitalized. However, there is still no clarity in the optimal (effective and efficient) protocol and dose for subacute patients undergoing outpatient therapy. This is why our proposal aims to answer the pending questions through a randomized clinical trial that includes patients in the subacute stage who have been discharged from the hospital. Furthermore, the optimal dose (stimulation time and number of sessions) would be defined which would allow clear, updated, and accurate evidence to be generated in these patients.
ASSUMPTIONS
It is reasonable to think that functional recovery tends to stabilize over time and that in a duration of 18 sessions could demonstrate the plateau.
HYPOTHESIS People with subacute stroke and moderate motor deficit of the upper limb who attend outpatient therapy and receive 18 sessions of 30 minutes of Bi-hemispheric Transcranial Direct Current Stimulation obtain at least 5% more functional recovery of the upper limb compared to those people who receive 18 sessions of 20 minutes of stimulation.
GENERAL OBJECTIVE Compare the evolution of functional recovery of the upper limb in people with subacute stroke who attend the Clinical Hospital of the University of Chile and the San José Hospital, after receiving bi-hemispheric transcranial stimulation by direct current, administered through a protocol of 18 30-minute sessions versus a protocol of 18 20-minute sessions.
METHODOLOGY AND PROCEDURES 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).
Interventions. Patients will be randomized to one of the following treatment groups: Experimental Group (30 minutes of bi-hemispheric tDCS combined with mCIMT for 18 sessions) or Active comparator Group (20 minutes of bi-hemispheric tDCS combined with mCIMT for 18 sessions).
General procedures.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 36 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University of Chile is the lead sponsor of 191 studies on the registry; 36 are open to participants now.
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Exclusion Criteria:
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
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
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.
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.
Time frame: 18 days, 3 and 6 months later
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.
Time frame: 18 days, 3 and 6 months later
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.
Time frame: 18 days, 3 and 6 months later
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.
Time frame: 18 days, 3 and 6 months later
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.
Time frame: 18 days, 3 and 6 months later
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.
Time frame: At the end of the treatment
No study locations are listed for this record.
Plan to share: Yes — The study protocol will be available in English and Spanish.
Supporting information: Study protocol
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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University of Chile