Parkinson's Disease and Gamma-transcranial Alternating Current Stimulation

Not Applicable

Recruiting

• Conditions: Parkinson Disease
• Interventions: Device: gamma transcranial alternating current stimulation (tACS); Device: sham transcranial alternating current stimulation (tACS)

• Registration Number: NCT06297538
• Lead Sponsor: Neuromed IRCCS

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-29
• Status Verified: 2024-02
• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-02-29
• Last Update Submitted: 2024-02-29
• Study First Posted: 2024-03-07
• Last Update Posted: 2024-03-07
• Primary Completion: 2024-10-29
• Study Completion: 2026-04-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
gamma transcranial alternating current stimulation	gamma transcranial alternating current stimulation (tACS)	-
sham transcranial alternating current stimulation	sham transcranial alternating current stimulation (tACS)	-

Primary Outcome Measures

Name	Time	Method
Changes in bradykinesia features as objectively assessed by kinematic techniques	post 5, 15 and 30 minutes	The velocity of finger tapping movements will be kinematically measured and expressed in degrees/second.
Changes in motor learning performance as objectively assessed by kinematic techniques	post 5, 15 and 30 minutes	The acceleration peak of finger index abductions will me kinematically measured and expressed as millimeters/seconds

Trial Locations

Locations (1)

IRCCS Neuromed; 🇮🇹 Pozzilli, Italy