NIBS With mCIMT for Motor and Functional Upper Limb Recovery in Stroke Patients.

Not Applicable

Completed

• Conditions: Upper Extremity Paresis; Electric Stimulation; Stroke; Occupational Therapy
• Interventions: Device: Sham Bihemispheric Transcranial direct current Stimulation; Device: Active Bihemispheric Transcranial direct current Stimulation; Other: Modified Constraint Induced Movement Therapy

• Registration Number: NCT03452254
• Lead Sponsor: University of Chile

Brief Summary

Stroke is one of the leading causes of serious long-term impairment. According to the estimates, 12,500 people suffer a new or recurrent ischemic stroke in Chile annually, which shows the magnitude of the problem. Motor impairment of the upper limb (UL) stands out as the principal sequel after a CVA (50% of the patients experience it), and the Constraint-Induced Movement Therapy (CIMT) is the rehabilitation approach that shows more scientific evidence today. Even though patients reach certain recuperation levels through this approach, results are still insufficient since 50-80% of the patients continue having upper limb motor impairment after completing standard rehabilitation. Because of this, it is pertinent to conduct research to explore new rehabilitation strategies to reduce the impairment indexes and to provide information for decision making based on evidence.

Recent studies on functional neuroimaging propose that there is an abnormal balance in the motor cortex excitability after stroke - relative under-excitability in the affected hemisphere and over-excitability in the unaffected hemisphere (with the consequent inhibitory influence on ipsilesional regions) in stroke patient with moderate motor impairment. This imbalance in the hemispheres function would limit the possibilities of a greater recovery. Then, in order to reestablish brain balance, the investigators proposed that the early introduction of noninvasive techniques of brain stimulation, such as tDCS, to the motor rehabilitation training could promote improvement of upper limb function in patients with stroke. However, we lack studies that confirm the benefits of using these techniques, define the most appropriate protocols, and determine what patients and under which evolving stages would be the best candidates for treatment.

This study aims to "compare the effectiveness of seven days of bi-hemispheric tDCS, both active and sham, combined with modified CIMT (mCIMT) in the motor and functional recovery of the hemiparetic upper limb in hospitalized patients with subacute unihemispheric stroke at Hospital Clínico de la Universidad de Chile and Hospital San José". This comparison responds to the hypothesis that patients who receive bi-hemispheric and active tDCS combined with mCIMT (experimental group) get at least 30% more recovery of the paretic upper limb compared to the control group who receive sham bi-hemispheric tDCS plus mCIMT after a protocol of seven days treatment.

Detailed Description

To test this hypothesis, the investigators propose to carry out a sham randomized multicenter double blind clinical trial. This trial considers seven continuous days of treatment when the participants with hemiparesis as a result of a stroke will be assigned to one of the treatment groups: bi-hemispheric tDCS combined with mCIMT or bi-hemispheric sham tDCS combined with mCIMT. Besides collecting demographic and clinical info from the subjects, the investigators will assess the patients using upper limb scales of functional motor recovery and an evaluation of their functional independence in basic activities of daily living (ADLs). STATA 14.0 software will be used for data analysis.

To date, no study has tested the efficacy of early bi-hemispheric stimulation in combination with mCIMT in subacute hospitalized stroke patients.

Study Timeline

• Study First Submitted: 2018-02-26
• Study First Submitted QC: 2018-02-26
• Study First Posted: 2018-03-02
• Study Start: 2018-06-04
• Primary Completion: 2021-03-30
• Study Completion: 2021-06-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-01
• Last Update Posted: 2021-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• First unihemispheric stroke event, ischemic or hemorrhagic, cortical or subcortical.
• Hemiparesis with unilateral brachial compromise.
• Evolution time ≥ 2 days. (equal or more than 2 days after onset)
• Patient must be 18 years old or older.
• Showing ability to perform some movement with the upper limb: at least 20º active extension of the wrist and 10º extension in fingers and/or 20° abduction angle in the shoulder.
• Informed consent signed by the patient.

Exclusion Criteria

• Previous central injury with motor sequelae.
• Severe aphasia with a score ≥ 2 in the language item of the National Institutes of Health Stroke Scale assessment.
• Severe cognitive impairment with a score < 15 points in the Mini-mental state examination.
• Shoulder subluxation and/or pain > 4 points in the Visual Numeric Scale for pain.
• Non-controlled epilepsy or epileptic seizures in the last three months.
• Metal implants or pacemaker.
• Pregnancy.
• Any other condition that, in the responsible physician's opinion, could prevent the correct development of the treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Modified Constraint Induced Movement Therapy	Active bi-hemispheric transcranial Direct Current Stimulation combined with modified Constraint Induced Movement Therapy.
Control Group	Sham Bihemispheric Transcranial direct current Stimulation	Sham bi-hemispheric transcranial Direct Current Stimulation combined with modified Constraint Induced Movement Therapy.
Experimental Group	Active Bihemispheric Transcranial direct current Stimulation	Active bi-hemispheric transcranial Direct Current Stimulation combined with modified Constraint Induced Movement Therapy.
Control Group	Modified Constraint Induced Movement Therapy	Sham bi-hemispheric transcranial Direct Current Stimulation combined with modified Constraint Induced Movement Therapy.

Primary Outcome Measures

Name	Time	Method
Upper Limb Motor Recovery.	7 days.	Percentage of the upper limb motor recovery after seven days treatment as assessed by Fugl Meyer Upper Extremity.
Upper Limb Functional Recovery.	7 days.	Percentage of the upper limb functional recovery after seven days treatment as assessed by Wolf Motor Function Test.

Secondary Outcome Measures

Name	Time	Method
Upper Limb Motor Recovery.	10 days and 3 months later	Percentage maintenance of the upper limb motor recovery after seven days treatment as Assessed by Fugl Meyer Upper Extremity.
Quality of life post-stroke	At the third month	Score in quality of life with stroke impact scale
Upper Limb Functional Recovery.	10 days	Percentage maintenance of the upper limb functional recovery after seven days treatment as assessed by Wolf Motor Function Test.
Independence in basic activities of daily living.	10 days and 3 months later	Obtained score of independence in basic activities of daily living after seven days treatment as Assessed by Functional Independence Measure (FIM).
Brain activation patterns.	7 days.	Effect on brain activation patterns of six patients after going through a protocol of seven days treatment.

Trial Locations

Locations (2)

Hospital San José; 🇨🇱 Santiago, Metropolitana, Chile

Hospital Clinico Universidad de Chile; 🇨🇱 Santiago, Metropolitana, Chile