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

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
tDCS
Conventional rehabilitative treatment
Sponsored by
I.R.C.C.S. Fondazione Santa Lucia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Rehabilitation, tDCS, Neurofilament, Neurofilament light chain, NfL, Transcranial direct current stimulation

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • I.R.C.C.S. Fondazione Santa LuciaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control Group

Arm Description

Standard rehabilitative treatment for stroke + tDCS

Only standard rehabilitative treatment for stroke

Outcomes

Primary Outcome Measures

To assess the change of blood value of Neurofilament light chain (NfL)
Evaluation of neurodegeneration after stroke

Secondary Outcome Measures

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.
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)
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
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
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
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.
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.
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.

Full Information

First Posted
April 7, 2023
Last Updated
April 20, 2023
Sponsor
I.R.C.C.S. Fondazione Santa Lucia
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1. Study Identification

Unique Protocol Identification Number
NCT05821816
Brief Title
Effect of Transcranial Direct Current Stimulation (tDCS) on Post-stroke Patients on Neuromotor Recovery
Official Title
Evaluation of the Efficacy of Transcranial Direct Current Stimulation (tDCS) on Neurodegeneration and Neuromotor Recovery on Post-stroke Patients. A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2023 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
I.R.C.C.S. Fondazione Santa Lucia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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;

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Rehabilitation, tDCS, Neurofilament, Neurofilament light chain, NfL, Transcranial direct current stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Standard rehabilitative treatment for stroke + tDCS
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Only standard rehabilitative treatment for stroke
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
Use of Transcranial direct current stimulation for 20 minutes per day, 5 days a week, at 2mA
Intervention Type
Other
Intervention Name(s)
Conventional rehabilitative treatment
Intervention Description
Physiotherapy treatment consisting in two treatments per day of 40 minutes each
Primary Outcome Measure Information:
Title
To assess the change of blood value of Neurofilament light chain (NfL)
Description
Evaluation of neurodegeneration after stroke
Time Frame
Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment
Secondary Outcome Measure Information:
Title
To assess the change of the Fugl-Meyer Assessment for upper extremity (FMA-UE)
Description
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.
Time Frame
Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment
Title
To assess the change of Modified Ashwort Scale (MAS)
Description
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)
Time Frame
Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment
Title
To assess the change of The Rivermead Mobility Index (RMI)
Description
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
Time Frame
Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment
Title
To assess the change of Barthel Index (BI)
Description
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
Time Frame
Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment
Title
To assess the change of Functional Ambulation Categories (FAC)
Description
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
Time Frame
Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment
Title
To assess the change of Canadian Neurological Scale (CNS)
Description
The Canadian Neurological Scale (CNS) provides a standarized neurological assessment of cognitive and motor function in stroke patients.
Time Frame
Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment
Title
To assess the change of Timed Up and Go Test (TUG)
Description
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.
Time Frame
Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment
Title
To assess the change of 2 Minute Walk Test (2MWT)
Description
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.
Time Frame
Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noemi Gentileschi
Phone
0651501845
Ext
+39
Email
n.gentileschi@hsantalucia.it
First Name & Middle Initial & Last Name or Official Title & Degree
Giulia Sancesario
Phone
06 51501399
Ext
+39
Email
g.sancesario@hsantalucia.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Brunelli, MD
Organizational Affiliation
I.R.C.C.S. Fondazione Santa Lucia, Roma, Italy
Official's Role
Study Director
Facility Information:
Facility Name
I.R.C.C.S. Fondazione Santa Lucia
City
Roma
ZIP/Postal Code
00179
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Brunelli, MD
Phone
0651501844
Ext
+39
Email
s.brunelli@hsantalucia.it
First Name & Middle Initial & Last Name & Degree
Noemi Gentileschi
Phone
0651501845
Ext
+39
Email
n.gentileschi@hsantalucia.it

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices)
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication
IPD Sharing Access Criteria
Proposals should be directed to the personal corrisponding author's mail address.
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Effect of Transcranial Direct Current Stimulation (tDCS) on Post-stroke Patients on Neuromotor Recovery

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