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Parkinson's Disease and Gamma-transcranial Alternating Current Stimulation

NCT06297538 · Neuromed IRCCS
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Official title
Targeting the Motor Cortex in Parkinson's Disease by Gamma-transcranial Alternating Current Stimulation: Pathophysiological and Therapeutic Implications
About this study
Cortical-basal ganglia gamma oscillations are pathologically reduced in Parkinson's disease (PD) and the plasticity of the primary motor cortex (M1) is impaired. Enhancing gamma oscillations through transcranial alternating current stimulation (tACS), a non-invasive neurophysiological tool that modulates cortical rhythms, can restore this alteration. However, whether tACS-related normalization of M1 plasticity results in positive clinical effects is unknown. Motor learning is also impaired in PD and gamma oscillations play a relevant role in different forms of learning in humans. Nevertheless, whether motor learning abnormalities relate to reduced gamma oscillations in PD is another unclear issue. It can be hypothesized that gamma oscillations impairment in M1 contributes to altered motor control, plasticity and learning in PD. Accordingly, in this project, the authors intend to test whether gamma-tACS on M1 in PD patients ameliorates motor performance and learning, as objectively assessed with kinematic techniques.
Eligibility criteria
Inclusion Criteria: * PD diagnosis Exclusion Criteria: * severe cognitive and psychiatric comorbidities * H\&Y\>3 * levodopa-induced dyskinesia and tremor-dominant phenotype * history of additional neuropsychiatric disorders * intake of medications acting on brain excitability or plasticity * contraindications to non-invasive brain stimulation
Study design
Enrollment target: 84 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2023-04-29
Estimated completion: 2026-04-29
Last updated: 2024-03-07
Interventions
Device: gamma transcranial alternating current stimulation (tACS)Device: sham transcranial alternating current stimulation (tACS)
Primary outcomes
  • Changes in bradykinesia features as objectively assessed by kinematic techniques (post 5, 15 and 30 minutes)
  • Changes in motor learning performance as objectively assessed by kinematic techniques (post 5, 15 and 30 minutes)
Sponsor
Neuromed IRCCS · other
With: Fondazione Policlinico Universitario Campus Bio-Medico, I.R.C.C.S. Fondazione Santa Lucia
Contacts & investigators
ContactGiulia Paparella · contact · giulia.paparella@uniroma1.it · 3384780752
All locations (1)
IRCCS NeuromedRecruiting
Pozzilli, Italy
Parkinson's Disease and Gamma-transcranial Alternating Current Stimulation · TrialPath