Transcranial Direct Current Stimulation of the Primary Motor Cortex to Treat Levodopa-induced Dyskinesias

NCT ID: NCT05752240

Last Updated: 2023-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-10

Study Completion Date

2025-03-10

Brief Summary

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The main objective of the study is to evaluate the efficacy of 10 sessions of transcranial direct current stimulation of the primary motor cortex to reduce levodopa-induced dyskinesia

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Active stimulation

Ten sessions of cathodic transcranial direct current stimulation over primary motor cortex

Group Type EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type DEVICE

Ten sessions of transcranial direct current stimulation over primary motor cortex to treat levodopa-induced dyskinesia

Sham stimulation

Ten sessions of sham stimulation over primary motor cortex

Group Type SHAM_COMPARATOR

Transcranial direct current stimulation

Intervention Type DEVICE

Ten sessions of transcranial direct current stimulation over primary motor cortex to treat levodopa-induced dyskinesia

Interventions

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Transcranial direct current stimulation

Ten sessions of transcranial direct current stimulation over primary motor cortex to treat levodopa-induced dyskinesia

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients with diagnosis of idiopathic Parkinson's disease according to Movement Disorder Society (MDS) criteria and levodopa-induced dyskinesia;
* 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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Flavia Torlizzi

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Francesco Bove, MD

Role: CONTACT

+390630156433

Facility Contacts

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Flavia Torlizzi

Role: primary

+390630156433

Other Identifiers

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3944

Identifier Type: -

Identifier Source: org_study_id

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