NCT05766059 Novel Non-invasive Brain Stimulation Techniques in Neurological Rehabilitation
| NCT ID | NCT05766059 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Auxologico Italiano |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2023-02-08 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2023-02-08 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Nadia Bolognini, PhD
PRINCIPAL INVESTIGATOR
Laboratorio di Neuropsicologia, IRCCS Istituto Auxologico Italiano
Frequently Asked Questions
Who can join the NCT05766059 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05766059 currently recruiting?
Yes, NCT05766059 is actively recruiting participants. Contact the research team at n.bolognini@auxologico.it for enrollment information.
Where is the NCT05766059 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT05766059 clinical trial?
NCT05766059 is sponsored by Istituto Auxologico Italiano. The principal investigator is Nadia Bolognini, PhD at Laboratorio di Neuropsicologia, IRCCS Istituto Auxologico Italiano. The trial plans to enroll 36 participants.
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