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Clinical Trials/NCT05795088
NCT05795088
Recruiting
Not Applicable

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country60 target enrollmentJune 16, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Enrollment
60
Locations
1
Primary Endpoint
Alterations of synaptic depotentiation in primary motor cortex
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 16, 2022
End Date
February 28, 2025
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Alterations of synaptic depotentiation in primary motor cortex

Time Frame: 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.

Study Sites (1)

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