Brain Connectivity Analysis

Not Applicable

Active, not recruiting

• Conditions: Neural Injury

• Registration Number: NCT06823102
• Lead Sponsor: IRCCS San Raffaele Roma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-28
• Primary Completion: 2024-04-28
• Status Verified: 2025-01
• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-02-07
• Last Update Submitted: 2025-02-07
• Study First Posted: 2025-02-12
• Last Update Posted: 2025-02-12
• Study Completion: 2026-04-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Casa di cura San Raffaele Pisana; 🇮🇹 Rome, Italy