Brain Connectivity Analysis

N/AActive Not RecruitingNCT06823102

IRCCS San Raffaele Roma75 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Neural Injury

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: From month 15 to the end of project

Predict patients' outcome

Use of AI to predict the outcome of the patient

Time frame: through study completion, an average of 1 year