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

I

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Enrolling

Conditions

Parkinson Disease

Treatments

Device: Continuous theta burst stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05795088
3884 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

Patients with parkinson's disease
Experimental group
Treatment:
Device: Continuous theta burst stimulation

Trial contacts and locations

1

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Central trial contact

Francesco Bove, MD

Data sourced from clinicaltrials.gov

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