NCT06823102

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 28, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2026

Completed
Last Updated

February 12, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

January 29, 2025

Last Update Submit

February 7, 2025

Conditions

Neural Injury

Keywords

Non Invasive Brain StimulationInflammation

Outcome Measures

Primary Outcomes (5)

  • 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

    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

    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

    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

    From month 15 to the end of project

  • Predict patients' outcome

    Use of AI to predict the outcome of the patient

    through study completion, an average of 1 year

Study Arms (3)

tDCS+standard rehabilitation

EXPERIMENTAL
Other: tDCS

tDCS sham+standard rehabilitation

SHAM COMPARATOR
Other: tDCS

standard rehabilitation

NO INTERVENTION

Interventions

tDCSOTHER

Transcranial direct current stimulation

tDCS sham+standard rehabilitationtDCS+standard rehabilitation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-90
  • First ischemic stroke occurring 3-30 days after onset
  • Residual upper limb function
  • Ability to provide informed consent and understand instructions

You may not qualify if:

  • Severe spasticity (Ashworth \>2)
  • Presence of additional neurological diseases
  • Significant comorbidities
  • History of intracerebral hemorrhage
  • Severe neglect
  • Contraindications to tDCS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Casa di cura San Raffaele Pisana

Rome, Rome, 00163, Italy

Location

MeSH Terms

Conditions

Inflammation

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2025

First Posted

February 12, 2025

Study Start

April 28, 2023

Primary Completion

April 28, 2024

Study Completion

April 27, 2026

Last Updated

February 12, 2025

Record last verified: 2025-01

Locations

IT(1)