StrokeNCT05821816
Effect of Transcranial Direct Current Stimulation (tDCS) on Post-stroke Patients on Neuromotor Recovery
A study testing tDCS and Conventional rehabilitative treatment in people with Stroke, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke
- What is being tested?
- tDCS and Conventional rehabilitative treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 2 Mar 2023to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- partecipants with a first episode of ischemic or hemorrhagic stroke
- partecipants must be enrolled within 30 days from the stroke
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Transcranial Direct Current Stimulation (tDCS) on Neurodegeneration and Neuromotor Recovery on Post-stroke Patients. a Pilot Study
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.
Read the 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;
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Use of Transcranial direct current stimulation for 20 minutes per day, 5 days a week, at 2mA
Conventional rehabilitative treatmentOther
Physiotherapy treatment consisting in two treatments per day of 40 minutes each
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Standard rehabilitative treatment for stroke + tDCS Receives: Device: tDCS; Other: Conventional rehabilitative treatment |
| Control Group | Active comparator | Only standard rehabilitative treatment for stroke Receives: Other: Conventional rehabilitative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the change of blood value of Neurofilament light chain (NfL)
Evaluation of neurodegeneration after stroke
Measured: Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment
Secondary outcomes (8)
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.
Measured: Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment
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)
Measured: Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment
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
Measured: Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment
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
Measured: Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment
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
Measured: Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment
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.
Measured: Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment
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.
Measured: Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment
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.
Measured: Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start2 Mar 2023
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Brunelli, I.R.C.C.S. Fondazione Santa Lucia
- Investigators
- Stefano Brunelli, MD, Study director, I.R.C.C.S. Fondazione Santa Lucia, Roma, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821816
- Sponsor's protocol ID
- Prot. CE/2022_031
- Status last verified
- Sep 2024
- First submitted
- 7 Apr 2023
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices)
Publications
Allman C, Amadi U, Winkler AM, Wilkins L, Filippini N, Kischka U, Stagg CJ, Johansen-Berg H. Ipsilesional anodal tDCS enhances the functional benefits of rehabilitation in patients after stroke. Sci Transl Med. 2016 Mar 16;8(330):330re1. doi: 10.1126/scitranslmed.aad5651. Epub 2016 Mar 16.
PubMed 27089207Barro C, Chitnis T, Weiner HL. Blood neurofilament light: a critical review of its application to neurologic disease. Ann Clin Transl Neurol. 2020 Dec;7(12):2508-2523. doi: 10.1002/acn3.51234. Epub 2020 Nov 4.
PubMed 33146954Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.
PubMed 27372845Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
PubMed 3809245Bolognini N, Vallar G, Casati C, Latif LA, El-Nazer R, Williams J, Banco E, Macea DD, Tesio L, Chessa C, Fregni F. Neurophysiological and behavioral effects of tDCS combined with constraint-induced movement therapy in poststroke patients. Neurorehabil Neural Repair. 2011 Nov-Dec;25(9):819-29. doi: 10.1177/1545968311411056. Epub 2011 Jul 29.
PubMed 21803933Collen FM, Wade DT, Robb GF, Bradshaw CM. The Rivermead Mobility Index: a further development of the Rivermead Motor Assessment. Int Disabil Stud. 1991 Apr-Jun;13(2):50-4. doi: 10.3109/03790799109166684.
PubMed 1836787Di Lazzaro V, Dileone M, Capone F, Pellegrino G, Ranieri F, Musumeci G, Florio L, Di Pino G, Fregni F. Immediate and late modulation of interhemipheric imbalance with bilateral transcranial direct current stimulation in acute stroke. Brain Stimul. 2014 Nov-Dec;7(6):841-8. doi: 10.1016/j.brs.2014.10.001. Epub 2014 Oct 13.
PubMed 25458712Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
PubMed 1135616Gattringer T, Pinter D, Enzinger C, Seifert-Held T, Kneihsl M, Fandler S, Pichler A, Barro C, Grobke S, Voortman M, Pirpamer L, Hofer E, Ropele S, Schmidt R, Kuhle J, Fazekas F, Khalil M. Serum neurofilament light is sensitive to active cerebral small vessel disease. Neurology. 2017 Nov 14;89(20):2108-2114. doi: 10.1212/WNL.0000000000004645. Epub 2017 Oct 18.
PubMed 29046363Gentil BJ, Tibshirani M, Durham HD. Neurofilament dynamics and involvement in neurological disorders. Cell Tissue Res. 2015 Jun;360(3):609-20. doi: 10.1007/s00441-014-2082-7. Epub 2015 Jan 8.
PubMed 25567110Holden MK, Gill KM, Magliozzi MR, Nathan J, Piehl-Baker L. Clinical gait assessment in the neurologically impaired. Reliability and meaningfulness. Phys Ther. 1984 Jan;64(1):35-40. doi: 10.1093/ptj/64.1.35.
PubMed 6691052Khalil M, Teunissen CE, Otto M, Piehl F, Sormani MP, Gattringer T, Barro C, Kappos L, Comabella M, Fazekas F, Petzold A, Blennow K, Zetterberg H, Kuhle J. Neurofilaments as biomarkers in neurological disorders. Nat Rev Neurol. 2018 Oct;14(10):577-589. doi: 10.1038/s41582-018-0058-z.
PubMed 30171200Khedr EM, Shawky OA, El-Hammady DH, Rothwell JC, Darwish ES, Mostafa OM, Tohamy AM. Effect of anodal versus cathodal transcranial direct current stimulation on stroke rehabilitation: a pilot randomized controlled trial. Neurorehabil Neural Repair. 2013 Sep;27(7):592-601. doi: 10.1177/1545968313484808. Epub 2013 Apr 22.
PubMed 23609526MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
PubMed 14258950Sattler V, Acket B, Raposo N, Albucher JF, Thalamas C, Loubinoux I, Chollet F, Simonetta-Moreau M. Anodal tDCS Combined With Radial Nerve Stimulation Promotes Hand Motor Recovery in the Acute Phase After Ischemic Stroke. Neurorehabil Neural Repair. 2015 Sep;29(8):743-54. doi: 10.1177/1545968314565465. Epub 2015 Jan 7.
PubMed 25567120
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Transcranial Direct Current Stimulation (tDCS) on Neurodegeneration and Neuromotor Recovery on Post-stroke Patients. a Pilot Study
- ClinicalTrials.gov ID
- NCT05821816
- Acronym / sponsor ID
- Prot. CE/2022_031
- Conditions
- Stroke
- Keywords
- Stroke, Rehabilitation, tDCS, Neurofilament, Neurofilament light chain, NfL, Transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: tDCS, Other: Conventional rehabilitative treatmentStandard rehabilitative treatment for stroke + tDCS |
| Control Group | Active comparator | Other: Conventional rehabilitative treatmentOnly standard rehabilitative treatment for stroke |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- partecipants with a first episode of ischemic or hemorrhagic stroke
- partecipants must be enrolled within 30 days from the stroke
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSUse of Transcranial direct current stimulation for 20 minutes per day, 5 days a week, at 2mA | Device | Experimental Group |
| Conventional rehabilitative treatmentPhysiotherapy treatment consisting in two treatments per day of 40 minutes each | Other | Control Group, Experimental Group |
Primary outcome
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
8 secondary outcomes
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Background: PubMed 27089207Allman C, Amadi U, Winkler AM, Wilkins L, Filippini N, Kischka U, Stagg CJ, Johansen-Berg H. Ipsilesional anodal tDCS enhances the functional benefits of rehabilitation in patients after stroke. Sci Transl Med. 2016 Mar 16;8(330):330re1. doi: 10.1126/scitranslmed.aad5651. Epub 2016 Mar 16.
- Background: PubMed 33146954Barro C, Chitnis T, Weiner HL. Blood neurofilament light: a critical review of its application to neurologic disease. Ann Clin Transl Neurol. 2020 Dec;7(12):2508-2523. doi: 10.1002/acn3.51234. Epub 2020 Nov 4.
- Background: PubMed 27372845Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.
- Background: PubMed 3809245Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
- Background: PubMed 21803933Bolognini N, Vallar G, Casati C, Latif LA, El-Nazer R, Williams J, Banco E, Macea DD, Tesio L, Chessa C, Fregni F. Neurophysiological and behavioral effects of tDCS combined with constraint-induced movement therapy in poststroke patients. Neurorehabil Neural Repair. 2011 Nov-Dec;25(9):819-29. doi: 10.1177/1545968311411056. Epub 2011 Jul 29.
- Background: PubMed 1836787Collen FM, Wade DT, Robb GF, Bradshaw CM. The Rivermead Mobility Index: a further development of the Rivermead Motor Assessment. Int Disabil Stud. 1991 Apr-Jun;13(2):50-4. doi: 10.3109/03790799109166684.
- Background: PubMed 25458712Di Lazzaro V, Dileone M, Capone F, Pellegrino G, Ranieri F, Musumeci G, Florio L, Di Pino G, Fregni F. Immediate and late modulation of interhemipheric imbalance with bilateral transcranial direct current stimulation in acute stroke. Brain Stimul. 2014 Nov-Dec;7(6):841-8. doi: 10.1016/j.brs.2014.10.001. Epub 2014 Oct 13.
- Background: PubMed 1135616Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
- Background: PubMed 29046363Gattringer T, Pinter D, Enzinger C, Seifert-Held T, Kneihsl M, Fandler S, Pichler A, Barro C, Grobke S, Voortman M, Pirpamer L, Hofer E, Ropele S, Schmidt R, Kuhle J, Fazekas F, Khalil M. Serum neurofilament light is sensitive to active cerebral small vessel disease. Neurology. 2017 Nov 14;89(20):2108-2114. doi: 10.1212/WNL.0000000000004645. Epub 2017 Oct 18.
- Background: PubMed 25567110Gentil BJ, Tibshirani M, Durham HD. Neurofilament dynamics and involvement in neurological disorders. Cell Tissue Res. 2015 Jun;360(3):609-20. doi: 10.1007/s00441-014-2082-7. Epub 2015 Jan 8.
- Background: PubMed 6691052Holden MK, Gill KM, Magliozzi MR, Nathan J, Piehl-Baker L. Clinical gait assessment in the neurologically impaired. Reliability and meaningfulness. Phys Ther. 1984 Jan;64(1):35-40. doi: 10.1093/ptj/64.1.35.
- Background: PubMed 30171200Khalil M, Teunissen CE, Otto M, Piehl F, Sormani MP, Gattringer T, Barro C, Kappos L, Comabella M, Fazekas F, Petzold A, Blennow K, Zetterberg H, Kuhle J. Neurofilaments as biomarkers in neurological disorders. Nat Rev Neurol. 2018 Oct;14(10):577-589. doi: 10.1038/s41582-018-0058-z.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices)
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Brunelli, MD study director
I.R.C.C.S. Fondazione Santa Lucia, Roma, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS and Conventional rehabilitative treatment in people with Stroke, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05821816, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.