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

Sponsor

I.R.C.C.S. Fondazione Santa Lucia (Other)

Overall Status

Recruiting

CT.gov ID

NCT05821816

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: tDCS Other: Conventional rehabilitative treatment	N/A

Detailed Description

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;

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 2, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Experimental Group

Standard rehabilitative treatment for stroke + tDCS

Device: tDCS

Use of Transcranial direct current stimulation for 20 minutes per day, 5 days a week, at 2mA

Other: Conventional rehabilitative treatment

Physiotherapy treatment consisting in two treatments per day of 40 minutes each

Active Comparator: Control Group

Only standard rehabilitative treatment for stroke

Other: Conventional rehabilitative treatment

Physiotherapy treatment consisting in two treatments per day of 40 minutes each

Outcome Measures

Primary Outcome Measures

To assess the change of blood value of Neurofilament light chain (NfL) [Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment]
Evaluation of neurodegeneration after stroke

Secondary Outcome Measures

To assess the change of the Fugl-Meyer Assessment for upper extremity (FMA-UE) [Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment]
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.
To assess the change of Modified Ashwort Scale (MAS) [Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment]
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)
To assess the change of The Rivermead Mobility Index (RMI) [Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment]
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
To assess the change of Barthel Index (BI) [Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment]
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
To assess the change of Functional Ambulation Categories (FAC) [Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment]
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
To assess the change of Canadian Neurological Scale (CNS) [Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment]
The Canadian Neurological Scale (CNS) provides a standarized neurological assessment of cognitive and motor function in stroke patients.
To assess the change of Timed Up and Go Test (TUG) [Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment]
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.
To assess the change of 2 Minute Walk Test (2MWT) [Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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