Back to resultsContinuous Theta Burst Stimulation as Potential Biomarker of Levodopa-induced Dyskinesias in Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Continuous theta burst stimulation
Sponsored by
About this trial
This is an interventional other trial for Parkinson Disease
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.
Sites / Locations
- Flavia TorlizziRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with parkinson's disease
Arm Description
Outcomes
Primary Outcome Measures
Alterations of synaptic depotentiation in primary motor cortex
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05795088
First Posted
February 21, 2023
Last Updated
March 20, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT05795088
Brief Title
Continuous Theta Burst Stimulation as Potential Biomarker of Levodopa-induced Dyskinesias in Parkinson's Disease
Official Title
Role of Continuous Theta Burst Stimulation as Potential Biomarker of Levodopa-induced Dyskinesias in Patients With Parkinson's Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with parkinson's disease
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Continuous theta burst stimulation
Intervention Description
Two sessions of continuous theta burst stimulation over primary motor cortex to explore synaptic plasticity in Patients with Parkinson's disease
Primary Outcome Measure Information:
Title
Alterations of synaptic depotentiation in primary motor cortex
Description
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.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Bove, MD
Phone
+390630156433
Email
francesco.bove@policlinicogemelli.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Calabresi, MD
Organizational Affiliation
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Flavia Torlizzi
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flavia Torlizzi
Phone
+390630156433
Email
flavia.torlizzi@policlinicogemelli.it
12. IPD Sharing Statement
Learn more about this trial
Continuous Theta Burst Stimulation as Potential Biomarker of Levodopa-induced Dyskinesias in Parkinson's Disease
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