Effect of Transcranial Direct Current Stimulation (tDCS) on Post-stroke Patients on Neuromotor Recovery

Study Overview
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Brief Summary
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The aim of the study is to evaluate whether a non-invasive brain stimulation technique (Transcranial Direct Current Stimulation) can influence the secondary neurodegeneration observed after a stroke (assessed based on serum concentration of neurofilaments) and can improve the functional outcome.

Detailed Description
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The present preliminary study aims to evaluate the effects of tDCS (transcranial direct current stimulation) on functional recovery in subacute stroke patients and on neurodegeneration, measuring Neurofilament light chain (NfL) in blood. It will evaluate: baseline NfL levels in patients with subacute stroke; the correlation between motor recovery and the blood concentration of NfL in subjects treated with tDCS compared to the control group. the effect of tDCS on motor recovery and NfL levels in the 3 months after the stroke event;

Official Title
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Evaluation of the Efficacy of Transcranial Direct Current Stimulation (tDCS) on Neurodegeneration and Neuromotor Recovery on Post-stroke Patients. A Pilot Study

Conditions
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Stroke

Intervention / Treatment
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* Device: tDCS
* Other: Conventional rehabilitative treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: partecipants with a first episode of ischemic or hemorrhagic stroke partecipants must be enrolled within 30 days from the stroke Exclusion Criteria: partecipants with previous episodes of ischemic or hemorrhagic stroke (evaluation by neuroimaging required) uncooperative patients medically unstable patients partecipants with any other neurodegenerative diseases epilepsies multiple ischemic lesions encephalic trunk ischemic lesions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Standard rehabilitative treatment for stroke + tDCS | Device: tDCS<br>* Use of Transcranial direct current stimulation for 20 minutes per day, 5 days a week, at 2mA<br>Other: Conventional rehabilitative treatment<br>* Physiotherapy treatment consisting in two treatments per day of 40 minutes each<br>|
| Active Comparator: Control Group<br>Only standard rehabilitative treatment for stroke | Other: Conventional rehabilitative treatment<br>* Physiotherapy treatment consisting in two treatments per day of 40 minutes each<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the change of blood value of Neurofilament light chain (NfL) | Evaluation of neurodegeneration after stroke | Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the change of the Fugl-Meyer Assessment for upper extremity (FMA-UE) | The Fugl-Meyer Assessment for upper extremity (FMA-UE) is a valid assessment tool of upper extremity motor function in persons with chronic stroke with moderate to severe deficits. It can determine disease severity, describe motor recovery, and to plan and assess treatment. | Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment | 
| To assess the change of Modified Ashwort Scale (MAS) | The Modified Ashworth Scale (MAS) is a 6-points ordinal scale used to assess muscle spasticity, measuring resistance during muscle passive stretching. It grades from 0 to 5: 0 means no increase in muscle tone (better outcome) and 5 means rigid (worse outcome) | Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment | 
| To assess the change of The Rivermead Mobility Index (RMI) | The Rivermead Mobility Index consists of 15 items (14 self reported items and 1 direct observation). The items are scored 0 if the patient is is not able to complete the task or 1 if they are able to complete it. The points are then added together, to score a maximum of 15, with higher scores stipulating better functional mobility | Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment | 
| To assess the change of Barthel Index (BI) | The Barthel Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge.Time taken and physical assistance required to perform each item are used in determining the assigned value of each item. The Barthel Index measures the degree of assistance required by an individual on 10 items of mobility and self care ADL | Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment | 
| To assess the change of Functional Ambulation Categories (FAC) | The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. The FAC does not evaluate endurance, as the patient is only required to walk approximately 10 ft | Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment | 
| To assess the change of Canadian Neurological Scale (CNS) | The Canadian Neurological Scale (CNS) provides a standarized neurological assessment of cognitive and motor function in stroke patients. | Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment | 
| To assess the change of Timed Up and Go Test (TUG) | The Timed Up and Go Test (TUG) is able to observe the patient's postural stability, gait, stride length, and sway. It determines fall risk and measures the progress of balance, sit to stand and walking. | Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment | 
| To assess the change of 2 Minute Walk Test (2MWT) | The Two/2 Minute Walk Test (2MWT) is a measure of self-paced walking ability and functional capacity. during this test the person is encouraged to walk at a comfortable speed, safely, without assistance for two minutes, measuring the distance walked, even with walking aids if necessary. | Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Rehabilitation, tDCS, Neurofilament, Neurofilament light chain, NfL, Transcranial direct current stimulation