Clinical trial NCT05821816: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Rehabilitation
tDCS
Neurofilament
Neurofilament light chain
NfL
Transcranial direct current stimulation
Lead sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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;

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

Primary outcomes:
measure: To assess the change of blood value of Neurofilament light chain (NfL)
timeFrame: Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment
Secondary outcomes:
measure: To assess the change of the Fugl-Meyer Assessment for upper extremity (FMA-UE)
timeFrame: Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment
measure: To assess the change of Modified Ashwort Scale (MAS)
timeFrame: Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment
measure: To assess the change of The Rivermead Mobility Index (RMI)
timeFrame: Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment
measure: To assess the change of Barthel Index (BI)
timeFrame: Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment
measure: To assess the change of Functional Ambulation Categories (FAC)
timeFrame: Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment
measure: To assess the change of Canadian Neurological Scale (CNS)
timeFrame: Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment
measure: To assess the change of Timed Up and Go Test (TUG)
timeFrame: Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment
measure: To assess the change of 2 Minute Walk Test (2MWT)
timeFrame: Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment
Other outcomes:
Locations:
city: Roma
country: Italy
facility: I.R.C.C.S. Fondazione Santa Lucia
Study officials:
affiliation: I.R.C.C.S. Fondazione Santa Lucia, Roma, Italy
name: Stefano Brunelli, MD
role: STUDY_DIRECTOR
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