Parkinson DiseaseNCT05795088
Continuous Theta Burst Stimulation as Potential Biomarker of Levodopa-induced Dyskinesias in Parkinson's Disease
A study testing Continuous theta burst stimulation in people with Parkinson Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Continuous theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 16 Jun 2022to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- patients unable to give informed consent;
- cognitive impairment (MMSE ≤ 24);
- history of epilepsy;
- pregnant women.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Flavia Torlizzi
Rome, 00168
Flavia Torlizzi, +390630156433, flavia.torlizzi@policlinicogemelli.it
About this study
Official title: Role of Continuous Theta Burst Stimulation as Potential Biomarker of Levodopa-induced Dyskinesias in Patients With Parkinson's Disease.
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.
- Conditions
- Parkinson Disease
- Being tested
- Continuous theta burst stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous theta burst stimulationDevice
Two sessions of continuous theta burst stimulation over primary motor cortex to explore synaptic plasticity in Patients with Parkinson's disease
| Study group | Role | What they receive |
|---|---|---|
| Patients with parkinson's disease | Experimental | Not described Receives: Device: Continuous theta burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start16 Jun 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo Calabresi, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795088
- Sponsor's protocol ID
- 3884
- Status last verified
- Feb 2023
- First submitted
- 21 Feb 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Continuous Theta Burst Stimulation as Potential Biomarker of Levodopa-induced Dyskinesias in Patients With Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT05795088
- Acronym / sponsor ID
- 3884
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with parkinson's disease | Experimental | Device: Continuous theta burst stimulation |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- patients unable to give informed consent;
- cognitive impairment (MMSE ≤ 24);
- history of epilepsy;
- pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous theta burst stimulationTwo sessions of continuous theta burst stimulation over primary motor cortex to explore synaptic plasticity in Patients with Parkinson's disease | Device | Patients with parkinson's disease |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Calabresi, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous theta burst stimulation in people with Parkinson Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Bove, MD (+390630156433, francesco.bove@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alterations of synaptic depotentiation in primary motor cortex (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.