Parkinson's Disease and Gamma-transcranial Alternating Current Stimulation

Parkinson Disease Clinical Trial

Official title:

Targeting the Motor Cortex in Parkinson's Disease by Gamma-transcranial Alternating Current Stimulation: Pathophysiological and Therapeutic Implications

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06297538
• Other study ID #: GR-2021-12372323
• Status: Recruiting
• Phase: N/A
• Start date: April 29, 2023
• Est. completion date: April 29, 2026

Study information

• Verified date: February 2024
• Source: Neuromed IRCCS
• Contact: Giulia Paparella
• Phone: 3384780752
• Email: giulia.paparella[@]uniroma1.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: April 29, 2026
• Est. primary completion date: October 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Italy	IRCCS Neuromed	Pozzilli

Sponsors (3)

Lead Sponsor	Collaborator
Neuromed IRCCS	Fondazione Policlinico Universitario Campus Bio-Medico, I.R.C.C.S. Fondazione Santa Lucia

Country where clinical trial is conducted

Italy, 

Outcome

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