Parkinson's Disease and Gamma-transcranial Alternating Current Stimulation

Neuromed IRCCS

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Device: gamma transcranial alternating current stimulation (tACS); Device: sham transcranial alternating current stimulation (tACS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06297538

GR-2021-12372323

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups

gamma transcranial alternating current stimulation

Experimental group

Treatment:

Device: gamma transcranial alternating current stimulation (tACS)

sham transcranial alternating current stimulation

Sham Comparator group

Treatment:

Device: sham transcranial alternating current stimulation (tACS)