Continuous Theta Burst Stimulation as Potential Biomarker of Levodopa-induced Dyskinesias in Parkinson's Disease

NCT ID: NCT05795088

Last Updated: 2023-04-03

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-16

Study Completion Date

2025-02-28

Brief Summary

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The primary endpoint of the study is to identify a neurophysiological biomarker (absence of synaptic depotentiation at primary motor cortex , measured as change in the amplitude of motor evoked potentials recorded at the dorsal first interosseus muscle after administration of neurophysiological cTBS depotentiation protocol) as predictor of the development of Levodopa-induced dyskinesia in patients with Parkinson's disease.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients with parkinson's disease

Group Type EXPERIMENTAL

Continuous theta burst stimulation

Intervention Type DEVICE

Two sessions of continuous theta burst stimulation over primary motor cortex to explore synaptic plasticity in Patients with Parkinson's disease

Interventions

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Continuous theta burst stimulation

Two sessions of continuous theta burst stimulation over primary motor cortex to explore synaptic plasticity in Patients with Parkinson's disease

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients with diagnosis of idiopathic Parkinson's disease according to Movement Disorder Society (MDS) criteria;
* age between 30 and 80 years;
* ongoing therapy with levodopa;
* fulfillment of requirements for the application of transcranial magnetic stimulation (TMS), assessed by completion of the TMS screening questionnaire.

Exclusion Criteria

* patients unable to give informed consent;
* cognitive impairment (MMSE ≤ 24);
* history of epilepsy;
* pregnant women.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paolo Calabresi, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Locations

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Flavia Torlizzi

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Francesco Bove, MD

Role: CONTACT

+390630156433

Facility Contacts

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Flavia Torlizzi

Role: primary

+390630156433

Other Identifiers

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3884

Identifier Type: -

Identifier Source: org_study_id

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