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Completed

NCT Number: NCT05821816

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Charcot-Marie-Tooth disease, Type 1F Nervous System Diseases Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

I.R.C.C.S. Fondazione Santa Lucia

Roma, Italy, 00179

About this study

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;

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tDCS

Device

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

Conventional rehabilitative treatment

Other

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

Primary outcomes

  1. To assess the change of blood value of Neurofilament light chain (NfL)

    Time frame: Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment

    Evaluation of neurodegeneration after stroke

Secondary outcomes

  1. To assess the change of the Fugl-Meyer Assessment for upper extremity (FMA-UE)

    Time frame: 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.

  2. To assess the change of Modified Ashwort Scale (MAS)

    Time frame: 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)

  3. To assess the change of The Rivermead Mobility Index (RMI)

    Time frame: 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

  4. To assess the change of Barthel Index (BI)

    Time frame: 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

  5. To assess the change of Functional Ambulation Categories (FAC)

    Time frame: 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

  6. To assess the change of Canadian Neurological Scale (CNS)

    Time frame: 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.

  7. To assess the change of Timed Up and Go Test (TUG)

    Time frame: 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.

  8. To assess the change of 2 Minute Walk Test (2MWT)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

I.R.C.C.S. Fondazione Santa Lucia

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 20, 2023
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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