Stroke
Conditions
Keywords
Stroke, Rehabilitation, tDCS, Neurofilament, Neurofilament light chain, NfL, Transcranial direct current stimulation
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;
Interventions
DEVICEtDCS
Use of Transcranial direct current stimulation for 20 minutes per day, 5 days a week, at 2mA
OTHERConventional rehabilitative treatment
Physiotherapy treatment consisting in two treatments per day of 40 minutes each
Sponsors
I.R.C.C.S. Fondazione Santa Lucia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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 |
Countries
Italy
Outcome results
None listed