Novel Non-invasive Brain Stimulation Techniques in Neurological Rehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorIstituto Auxologico Italiano
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
age from 18 to 90 years
Trial design
Design model
Sequential
Treatments tested in this trial
Transcranial Magnetic Stimulation
DeviceThe standard PAS protocol will be compared with the mirrorPAS protocol.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: [Phase 1] Stroke patients with upper-limb hemiparesisExperimental treatment 1 intervention
Group B: [Phase 2] Patients with phantom limb pain (PLP)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in motor-evoked potentials (MEP)
\[Phase 1, only in stroke patients\] peak-to-peak MEP amplitude
Time frame
At baseline and after the administration of the PAS protocols2
Change in functional mapping of phantom limb cortical areas
\[Phase 2, only in PLP patients\]
Time frame
At baseline and after the administration of the PAS protocolsSponsors and contacts
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Source ClinicalTrials.gov