Neural InjuryNeurehabNCT06823102
Brain Connectivity Analysis
A study testing tDCS in people with Neural Injury, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial summary
Stroke remains the leading cause of permanent disability. The neuromodulation technique of transcranial Direct Current Stimulation (tDCS) has the potential to serve as an adjuvant therapy to enhance neuronal connectivity following stroke. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neural Injury
- What is being tested?
- tDCS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteItaly
- Study dates
- 28 Apr 2023to 27 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-90
- First ischemic stroke occurring 3-30 days after onset
- Residual upper limb function
- Ability to provide informed consent and understand instructions
Who cannot join
- Severe spasticity (Ashworth >2)
- Presence of additional neurological diseases
- Significant comorbidities
- History of intracerebral hemorrhage
- Severe neglect
- Contraindications to tDCS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain Connectivity Analysis to Predict Post Stroke Outcomes Following Traditional and Enhanced Neurorehabilitation by Transcranial Direct Current Stimulation and Anti-inflammatory Biomimetic Nanoparticles
Stroke remains the leading cause of permanent disability. The neuromodulation technique of transcranial Direct Current Stimulation (tDCS) has the potential to serve as an adjuvant therapy to enhance neuronal connectivity following stroke. By combining electroencephalography (EEG) and tDCS, this study aims to investigate changes in network connectivity and cerebral plasticity, which are key factors in functional recovery after stroke.
The objectives are to: 1) analyze how tDCS modulates neuronal activity, 2) evaluate persistent effects in follow-up assessments, and 3) predict patient outcomes. Studies on human subjects will be complemented by research in a mouse model of stroke to: 1) identify the molecular mechanisms underlying tDCS effects on functional recovery, 2) establish correlations among functional, molecular, and connectivity indices, and 3) assess the efficacy of biomimetic nanoparticles in targeting injured brain tissue to reduce inflammation, enhance neuronal plasticity, and support functional recovery.
- Conditions
- Neural Injury
- Being tested
- tDCS
- Keywords
- Non Invasive Brain Stimulation, Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSOther
Transcranial direct current stimulation
| Study group | Role | What they receive |
|---|---|---|
| tDCS+standard rehabilitation | Experimental | Not described Receives: Other: tDCS |
| tDCS sham+standard rehabilitation | Sham comparator | Not described Receives: Other: tDCS |
| standard rehabilitation | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate effects of tDCS in short-term follow-ups in terms of EEG Coherence
Analysis of Magnitude Squared Coherence to evaluate short-term tDCS effects
Measured: from month 8 to month 12
Evaluate persistent effect of tDCS in long-term follow-ups of EEG Coherence
Analysis of Magnitude Squared Coherence evaluate long-term tDCS effects
Measured: From month 15 to the end of project
Evaluate effects of tDCS in short-term follow-ups in terms of EEG Connectivity
Analysis of EEG Connectivity to evaluate short-term tDCS effects
Measured: from month 8 to month 12
Evaluate persistent effect of tDCS in long-term follow-ups of EEG Connectivity
Analysis of EEG Connectivity to evaluate long-term tDCS effects
Measured: From month 15 to the end of project
Predict patients' outcome
Use of AI to predict the outcome of the patient
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start28 Apr 2023
- Primary completion28 Apr 2024
- Study completion27 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neural InjuryStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823102
- Sponsor's protocol ID
- RP 22/24
- Acronym
- Neurehab
- Status last verified
- Jan 2025
- First submitted
- 29 Jan 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Connectivity Analysis to Predict Post Stroke Outcomes Following Traditional and Enhanced Neurorehabilitation by Transcranial Direct Current Stimulation and Anti-inflammatory Biomimetic Nanoparticles
- ClinicalTrials.gov ID
- NCT06823102
- Acronym / sponsor ID
- Neurehab / RP 22/24
- Conditions
- Neural Injury
- Keywords
- Non Invasive Brain Stimulation, Inflammation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (actual)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 28 Apr 2024 (actual)
- Study completion
- 27 Apr 2026 (estimated)
- First posted
- 12 Feb 2025 (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.
Stroke remains the leading cause of permanent disability. The neuromodulation technique of transcranial Direct Current Stimulation (tDCS) has the potential to serve as an adjuvant therapy to enhance neuronal connectivity following stroke. By combining electroencephalography (EEG) and tDCS, this study aims to investigate changes in network connectivity and cerebral plasticity, which are key factors in functional recovery after stroke.
The objectives are to: 1) analyze how tDCS modulates neuronal activity, 2) evaluate persistent effects in follow-up assessments, and 3) predict patient outcomes. Studies on human subjects will be complemented by research in a mouse model of stroke to: 1) identify the molecular mechanisms underlying tDCS effects on functional recovery, 2) establish correlations among functional, molecular, and connectivity indices, and 3) assess the efficacy of biomimetic nanoparticles in targeting injured brain tissue to reduce inflammation, enhance neuronal plasticity, and support functional recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS+standard rehabilitation | Experimental | Other: tDCS |
| tDCS sham+standard rehabilitation | Sham comparator | Other: tDCS |
| standard rehabilitation | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-90
- First ischemic stroke occurring 3-30 days after onset
- Residual upper limb function
- Ability to provide informed consent and understand instructions
Key exclusion criteria (6 listed)
- Severe spasticity (Ashworth >2)
- Presence of additional neurological diseases
- Significant comorbidities
- History of intracerebral hemorrhage
- Severe neglect
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 |
|---|---|---|
| tDCSTranscranial direct current stimulation | Other | tDCS sham+standard rehabilitation, tDCS+standard rehabilitation |
Primary outcome
Evaluate effects of tDCS in short-term follow-ups in terms of EEG Coherence
Time frame: from month 8 to month 12
Analysis of Magnitude Squared Coherence to evaluate short-term tDCS effects
Evaluate persistent effect of tDCS in long-term follow-ups of EEG Coherence
Time frame: From month 15 to the end of project
Analysis of Magnitude Squared Coherence evaluate long-term tDCS effects
Evaluate effects of tDCS in short-term follow-ups in terms of EEG Connectivity
Time frame: from month 8 to month 12
Analysis of EEG Connectivity to evaluate short-term tDCS effects
Evaluate persistent effect of tDCS in long-term follow-ups of EEG Connectivity
Time frame: From month 15 to the end of project
Analysis of EEG Connectivity to evaluate long-term tDCS effects
Predict patients' outcome
Time frame: through study completion, an average of 1 year
Use of AI to predict the outcome of the patient
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
Related trials for Neural Injury
Not yet recruiting
Recurrent Laryngeal Nerve Monitoring During Pediatric Aerodigestive Tract and Cardiac Surgery
Unilateral Vocal Cord Paralysis, Unilateral Vocal Cord Paresis
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
Active, not recruiting
Sensory Motor Transformations in Human Cortex
Quadriplegia
Not yet recruitingObservational study
The Systemic Nature of Severe Traumatic Brain Injury
Severe Traumatic Brain Injury
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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Neural Injury, run by IRCCS San Raffaele Roma 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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Evaluate effects of tDCS in short-term follow-ups in terms of EEG Coherence (time frame: from month 8 to month 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2025.