Parkinson's Disease and Gamma-transcranial Alternating Current Stimulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-29

Study Completion Date

2026-04-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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gamma transcranial alternating current stimulation

Group Type EXPERIMENTAL

gamma transcranial alternating current stimulation (tACS)

Intervention Type DEVICE

Transcranial alternating current stimulation (tACS) will be delivered using a BrainSTIM (EMS, Italy) connected to two electrodes (5x5cm) enclosed in sponges soaked with saline solution. One electrode will be centred over the first dorsal interosseus (FDI) hotspot and the other over P3. tACS will be delivered at peak-to-peak amplitude of 1 milliampere (mA), and with 3-seconds ramp-up and down periods. The stimulation frequency will be 70 Hz, as representative of the endogenous motor network-related gamma frequency.

sham transcranial alternating current stimulation

Group Type SHAM_COMPARATOR

sham transcranial alternating current stimulation (tACS)

Intervention Type DEVICE

Sham-tACS will consist of ramp-up and down periods and only 1-second stimulation at 1 mA amplitude.

Interventions

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gamma transcranial alternating current stimulation (tACS)

Transcranial alternating current stimulation (tACS) will be delivered using a BrainSTIM (EMS, Italy) connected to two electrodes (5x5cm) enclosed in sponges soaked with saline solution. One electrode will be centred over the first dorsal interosseus (FDI) hotspot and the other over P3. tACS will be delivered at peak-to-peak amplitude of 1 milliampere (mA), and with 3-seconds ramp-up and down periods. The stimulation frequency will be 70 Hz, as representative of the endogenous motor network-related gamma frequency.

Intervention Type DEVICE

sham transcranial alternating current stimulation (tACS)

Sham-tACS will consist of ramp-up and down periods and only 1-second stimulation at 1 mA amplitude.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes