Parkinson's Disease and Gamma-transcranial Alternating Current Stimulation

February 29, 2024 updated by: Giulia Paparella, Neuromed IRCCS

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Pozzilli, Italy
        • Recruiting
        • IRCCS Neuromed
        • Contact:
          • Giulia Paparella
          • Phone Number: 3384780752

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: gamma transcranial alternating current stimulation
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 Comparator: sham transcranial alternating current stimulation
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuromed IRCCS

Collaborators

I.R.C.C.S. Fondazione Santa Lucia
Fondazione Policlinico Universitario Campus Bio-Medico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2023

Primary Completion (Estimated)

October 29, 2024

Study Completion (Estimated)

April 29, 2026

Study Registration Dates

First Submitted

February 22, 2024

First Submitted That Met QC Criteria

February 29, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GR-2021-12372323

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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