Brain Connectivity Analysis (Neurehab)

February 7, 2025 updated by: IRCCS San Raffaele Roma

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00163
        • Casa di cura San Raffaele Pisana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: standard rehabilitation
Experimental: tDCS+standard rehabilitation
Other: tDCS
Transcranial direct current stimulation
Sham Comparator: tDCS sham+standard rehabilitation
Other: tDCS
Transcranial direct current stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from month 8 to month 12
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
From month 15 to the end of project
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
from month 8 to month 12
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
From month 15 to the end of project
Predict patients' outcome
Time Frame: through study completion, an average of 1 year
Use of AI to predict the outcome of the patient
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele Roma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2023

Primary Completion (Actual)

April 28, 2024

Study Completion (Estimated)

April 27, 2026

Study Registration Dates

First Submitted

January 29, 2025

First Submitted That Met QC Criteria

February 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 7, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RP 22/24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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