Brain Connectivity Analysis (Neurehab)

IRCCS San Raffaele Roma

Status: Active, not recruiting

Conditions: Neural Injury

Treatments: Other: tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT06823102

RP 22/24

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups

tDCS+standard rehabilitation

Experimental group

Treatment:

Other: tDCS

tDCS sham+standard rehabilitation

Sham Comparator group

Treatment:

Other: tDCS

standard rehabilitation

No Intervention group