NCT06297538

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2024

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2026

Completed
Last Updated

March 7, 2024

Status Verified

February 1, 2024

Enrollment Period

1.5 years

First QC Date

February 22, 2024

Last Update Submit

February 29, 2024

Conditions

Parkinson Disease

Keywords

Parkinson's diseaseMotor cortexTranscranial magnetic stimulation

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

gamma transcranial alternating current stimulation

EXPERIMENTAL
Device: gamma transcranial alternating current stimulation (tACS)

sham transcranial alternating current stimulation

SHAM COMPARATOR
Device: sham transcranial alternating current stimulation (tACS)

Interventions

gamma transcranial alternating current stimulation (tACS)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.

gamma transcranial alternating current stimulation
sham transcranial alternating current stimulation (tACS)DEVICE

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

sham transcranial alternating current stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PD diagnosis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Neuromed

Pozzilli, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Giulia Paparella

CONTACT

3384780752giulia.paparella@uniroma1.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 22, 2024

First Posted

March 7, 2024

Study Start

April 29, 2023

Primary Completion

October 29, 2024

Study Completion

April 29, 2026

Last Updated

March 7, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)