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OpenTrials
Active, Not Recruiting

NCT Number: NCT06823102

Brain Connectivity Analysis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Neural Injury Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Casa di cura San Raffaele Pisana

Rome, 00163, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tDCS

Other

Transcranial direct current stimulation

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Predict patients' outcome

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

    Use of AI to predict the outcome of the patient

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele Roma

Other

Registry information

Official study title

Brain Connectivity Analysis to Predict Post Stroke Outcomes Following Traditional and Enhanced Neurorehabilitation by Transcranial Direct Current Stimulation and Anti-inflammatory Biomimetic Nanoparticles

Acronym: Neurehab

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Feb 12, 2025
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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