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Clinical Trials in Italy / NCT05766059
Recruiting Not applicable

Novel Non-invasive Brain Stimulation Techniques in Neurological Rehabilitation

NCT05766059 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Auxologico Italiano
Phase
Not applicable
Started
2023-02-08
Last updated
2025-09-17

Condition(s) studied

StrokeHemiparesisPhantom Limb Pain

Investigational drug(s) / intervention(s)

Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation: The standard PAS protocol will be compared with the mirrorPAS protocol.

Study summary

Paired associative stimulation (PAS) is a non-invasive brain stimulation protocol, where two stimuli (a peripheral and a cortical one, the latter delivered with transcranial magnetic stimulation - TMS) are repeatedly associated to enhance plasticity in the brain. In the present study, a new cross-modal, visuo-motor PAS protocol - called "mirror-PAS"- will be tested as a possible non-invasive brain stimulation treatment in neurological rehabilitation to promote motor recovery and pain reduction.

Participants will perform the standard PAS targeting the motor system and the recently developed mirror-PAS in two separate sessions. The investigators will compare the possible effect of the protocols in terms of neurophysiological and behavioral outcomes to identify the optimal PAS method to enhance plasticity and promote sensory-motor function.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion criteria for stroke patients: * age from 18 to 85 years * single, unilateral, hemispheric stroke (cortical or sub-cortical areas) * stroke confirmed by neuroimaging (CT or MRI) * stroke at least 4 months before enrollment * hemiparesis of the upper limb resulting from stroke or hemianesthesia clinically documented Exclusion criteria for stroke patients: * contraindications to TMS (Rossi et all, 2021) * other neurological conditions (e.g., Parkinson's Disease, Multiple Sclerosis, ALS) * other orthopedic condition that affected the hand (e.g., carpal tunnel syndrome) Inclusion criteria for PLP patients: * age from 18 to 90 years * amputation of one part of the upper limb at least 2 months before enrollment * presence of stable phantom limb pain at least 2 months prior to enrollment Exclusion criteria for PLP patients: * contraindications to TMS (Rossi et all, 2021) * other neurological, orthopedical or psychiatric conditions

Primary outcome measure(s)

  • Change from baseline in motor-evoked potentials (MEP) — At baseline and after the administration of the PAS protocols
    \[Phase 1, only in stroke patients\] peak-to-peak MEP amplitude
  • Change in functional mapping of phantom limb cortical areas — At baseline and after the administration of the PAS protocols
    \[Phase 2, only in PLP patients\]

Trial sites (1)

FacilityCityRegionStatus
Istituto Auxologico Italiano IRCCS Milan Lombardy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05766059 on ClinicalTrials.gov ↗ ← All trials in Italy