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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06396715
Other study ID # OAIC: 1390/23
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2024
Est. completion date December 26, 2025

Study information

Verified date April 2024
Source University of Chile
Contact Maricel Garrido
Phone +56229788038
Email mgarridom@hcuch.cl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Chile Agencia Nacional de Investigación y Desarrollo

References & Publications (8)

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Outcome

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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