Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
ID05766059

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

Led by Istituto Auxologico Italiano · Updated on 2025-09-17

36

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are exploring new non-invasive brain stimulation techniques to help improve motor recovery and reduce pain in people with neurological conditions such as stroke and phantom limb pain. This study evaluates a standard paired associative stimulation (PAS) protocol and a novel cross-modal "mirror-PAS" protocol that targets a broader visuomotor brain network. The goal is to understand which method better promotes brain plasticity and sensory-motor function. Participants will undergo two separate sessions receiving either the standard PAS or the mirror-PAS. The standard PAS uses paired stimuli to the motor system, while the mirror-PAS pairs a visual hand movement stimulus with transcranial magnetic stimulation (TMS) to the motor cortex. The study includes two phases: one with stroke patients experiencing upper-limb hemiparesis and another with patients suffering phantom limb pain after upper limb amputation. During the study, researchers will measure changes in motor-evoked potentials and brain mapping related to phantom limb areas before and after the PAS protocols. Participants will be monitored for neurophysiological and behavioral changes to assess the effects of each treatment. The study runs until September 2026 and involves regular assessments to track brain plasticity and functional improvements.

CONDITIONS

Brief Title

Novel Non-invasive Brain Stimulation Techniques in Neurological Rehabilitation

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age from 18 to 85 years for stroke patients
  • Single, unilateral, hemispheric stroke confirmed by CT or MRI
  • Stroke occurred at least 4 months before enrollment
  • Hemiparesis of the upper limb or hemianesthesia clinically documented
  • Age from 18 to 90 years for phantom limb pain (PLP) patients
  • Amputation of one upper limb part at least 2 months before enrollment
  • Presence of stable phantom limb pain for at least 2 months prior to enrollment
Not Eligible

You will not qualify if you...

  • Contraindications to transcranial magnetic stimulation (TMS)
  • Other neurological conditions such as Parkinson's Disease, Multiple Sclerosis, or ALS
  • Other orthopedic conditions affecting the hand, such as carpal tunnel syndrome
  • For PLP patients, any other neurological, orthopedic, or psychiatric conditions

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Implementation

Duration - Not specified

Participants receive non-invasive brain stimulation using Transcranial Magnetic Stimulation (TMS) with either the standard PAS protocol or the mirror-PAS protocol to promote motor recovery and brain plasticity.

Multiple visits for administration of PAS protocols

Follow-up

Duration - Not specified

Participants are assessed for changes in motor-evoked potentials and functional mapping after the PAS protocols to evaluate treatment effects.

1 to 2 visits post-treatment for outcome assessments

Trial Site Locations

Total: 1 location

1

Istituto Auxologico Italiano IRCCS

Milan, Lombardy, Italy, 20122

Actively Recruiting

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Research Team

N

Nadia Bolognini, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

OTHER

Number of Arms

2

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Published Research Related To This Trial

Induction of cortical plastic changes in wrist muscles by paired associative stimulation in the recovery phase of stroke patients.

Evelyne Castel-Lacanal, Philippe Marque, Jean Tardy...

https://pubmed.ncbi.nlm.nih.gov/19060132

Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines.

Simone Rossi, Andrea Antal, Sven Bestmann...

https://pubmed.ncbi.nlm.nih.gov/33243615