Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06396715
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-26
Brief Title:
Optimal Therapeutic Dose of tDCS for Functional Upper Limb Recovery in People With Stroke
Sponsor:
University of Chile
Organization:
University of Chile
Study Overview
Official Title:
Optimal Therapeutic Dose of Transcranial Direct Current Stimulation for Functional Upper Limb Recovery in People With Stroke Multicenter Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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
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 andor 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
Detailed Description:
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
The literature suggests that the best results of UL recovery in protocols that include tDCS are obtained with a moderate amount of total number of sessions comprising between 15-24 sessions but our local RCT showed results in 7 sessions
A very long therapy schedule is uncomfortable for the patient and caregiver and not very feasible to apply in our public health system which is why the investigators propose an intermediate duration of 18 sessions
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
During the protocol patients can continue participating in the usual interdisciplinary rehabilitation program in their hospitals but it is suggested that they do not add therapies associated with the upper limb while participating in the protocol as this may generate a risk of injury due to overuse
All patients will undergo neuromuscular taping on the deltoid of the paretic shoulder with weekly changes since it is part of the usual care at HCUCH
Patients should attend therapy wearing comfortable clothing t-shirt and sweatshirtshorts
Patients should be informed that if they experience pain or discomfort while performing activities at home practice should be temporarily suspended and the therapist notified A transfer package is prepared which will allow to monitor compliance with the CIMT protocol at home Some activities of the transfer package include the delivery of videos with therapeutic material and the activities to be performed at home as well as telephone follow-up to verify compliance with the completion of a check list-type guideline
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
The literature suggests that the best results of UL recovery in protocols that include tDCS are obtained with a moderate amount of total number of sessions comprising between 15-24 sessions but our local RCT showed results in 7 sessions
A very long therapy schedule is uncomfortable for the patient and caregiver and not very feasible to apply in our public health system which is why the investigators propose an intermediate duration of 18 sessions
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
During the protocol patients can continue participating in the usual interdisciplinary rehabilitation program in their hospitals but it is suggested that they do not add therapies associated with the upper limb while participating in the protocol as this may generate a risk of injury due to overuse
All patients will undergo neuromuscular taping on the deltoid of the paretic shoulder with weekly changes since it is part of the usual care at HCUCH
Patients should attend therapy wearing comfortable clothing t-shirt and sweatshirtshorts
Patients should be informed that if they experience pain or discomfort while performing activities at home practice should be temporarily suspended and the therapist notified A transfer package is prepared which will allow to monitor compliance with the CIMT protocol at home Some activities of the transfer package include the delivery of videos with therapeutic material and the activities to be performed at home as well as telephone follow-up to verify compliance with the completion of a check list-type guideline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None