Non-invasive brain stimulation techniques for neurological rehabilitation
Novel Non-invasive Brain Stimulation Techniques in Neurological Rehabilitation: Cross-modal Paired Associative Stimulation (PAS) Protocols to Promote Plastic Reorganization in Stroke and Phantom Limb Pain Patients
This study is testing a new brain stimulation method called 'mirror-PAS' to see if it can help people with neurological conditions like stroke and phantom limb pain recover movement and feel less pain compared to standard methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano Academic / other |
| Locations | 1 site (Milan, Lombardy) |
| Trial ID | NCT05766059 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a novel non-invasive brain stimulation protocol called 'mirror-PAS' in promoting motor recovery and reducing pain in patients with neurological conditions such as stroke and phantom limb pain. Participants will undergo two separate sessions of paired associative stimulation (PAS), one using standard methods and the other using the innovative mirror-PAS approach. The study aims to compare the neurophysiological and behavioral outcomes of both protocols to determine which is more effective in enhancing brain plasticity and sensory-motor function.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 90 with a history of stroke or upper limb amputation experiencing hemiparesis or phantom limb pain.
Not a fit: Patients with contraindications to transcranial magnetic stimulation or other neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve motor recovery and pain management for patients with neurological impairments.
How similar studies have performed: Previous studies have shown promise with similar non-invasive brain stimulation techniques, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milan, Lombardy
- Istituto Auxologico Italiano IRCCS — Milan, Lombardy, Italy (Recruiting)
Study contacts
- Principal investigator: Nadia Bolognini, PhD — Laboratorio di Neuropsicologia, IRCCS Istituto Auxologico Italiano
- Study coordinator: Nadia Bolognini, PhD
- Email: n.bolognini@auxologico.it
- Phone: +390261911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.