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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Recruiting
CT.gov ID
NCT05795088
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
32.5
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Continuous theta burst stimulation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Role of Continuous Theta Burst Stimulation as Potential Biomarker of Levodopa-induced Dyskinesias in Patients With Parkinson's Disease.
Actual Study Start Date :
Jun 16, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Feb 28, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients with parkinson's disease

Device: 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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Flavia Torlizzi Rome Italy 00168

Sponsors and Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Paolo Calabresi, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier:
NCT05795088
Other Study ID Numbers:
  • 3884
First Posted:
Apr 3, 2023
Last Update Posted:
Apr 3, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Parkinson Disease
Dyskinesias

Study Results

No Results Posted as of Apr 3, 2023