Neural Injury
Conditions
Keywords
Non Invasive Brain Stimulation, Inflammation
Brief 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. 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.
Interventions
OTHERtDCS
Transcranial direct current stimulation
Sponsors
IRCCS San Raffaele Roma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Age 18-90 * First ischemic stroke occurring 3-30 days after onset * Residual upper limb function * Ability to provide informed consent and understand instructions
Exclusion criteria
* Severe spasticity (Ashworth \>2) * Presence of additional neurological diseases * Significant comorbidities * History of intracerebral hemorrhage * Severe neglect * Contraindications to tDCS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate effects of tDCS in short-term follow-ups in terms of EEG Coherence | 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 | 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 | 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 | From month 15 to the end of project | Analysis of EEG Connectivity to evaluate long-term tDCS effects |
| Predict patients' outcome | through study completion, an average of 1 year | Use of AI to predict the outcome of the patient |
Countries
Italy
Outcome results
None listed