Brain Connectivity Analysis

NCT ID: NCT06823102

Last Updated: 2025-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-28

Study Completion Date

2026-04-27

Brief Summary

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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

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Conditions

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Neural Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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tDCS+standard rehabilitation

Group Type EXPERIMENTAL

tDCS

Intervention Type OTHER

Transcranial direct current stimulation

tDCS sham+standard rehabilitation

Group Type SHAM_COMPARATOR

tDCS

Intervention Type OTHER

Transcranial direct current stimulation

standard rehabilitation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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tDCS

Transcranial direct current stimulation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele Roma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Casa di cura San Raffaele Pisana

Rome, Rome, Italy

Site Status

Countries

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Italy

Other Identifiers

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RP 22/24

Identifier Type: -

Identifier Source: org_study_id

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