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

Not Applicable

Recruiting

• Conditions: Parkinson Disease
• Interventions: Device: Continuous theta burst stimulation

• Registration Number: NCT05795088
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-06-16
• Status Verified: 2023-02
• Study First Submitted: 2023-02-21
• Study First Submitted QC: 2023-03-20
• Last Update Submitted: 2023-03-20
• Study First Posted: 2023-04-03
• Last Update Posted: 2023-04-03
• Primary Completion: 2023-12-01
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with parkinson's disease	Continuous theta burst stimulation	-

Primary Outcome Measures

Name	Time	Method
Alterations of synaptic depotentiation in primary motor cortex	3 years	Alterations of synaptic depotentiation in primary motor cortex will be measured as change in the amplitude of motor evoked potentials recorded at the dorsal first interosseus muscle after administration of depotentiation protocol of continuous theta burst stimulation. Alterations of synaptic depotentiation at the baseline evaluation will be compared between patients who will develop and patients who will not develop dyskinesias (assessed by Unified Dyskinesia Rating Scale part III, range 0-112) during the follow-up.

Trial Locations

Locations (1)

Flavia Torlizzi; 🇮🇹 Rome, Italy