RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Accelerated intermittent theta-burst stimulation (iTBS) rTMS to left dorsomedial prefrontal cortex (dmPFC) for Parkinson Disease

This single-site, open-label pilot study will measure the feasibility, tolerability, and preliminary how well it works of accelerated intermittent theta-burst stimulation (iTBS) targeting the dorsomedial prefrontal cortex (dmPFC) for apathy in individuals with Parkinson's Disease (PD). Fifteen participants with PD and clinically significant apathy will undergo imaging (EEG and MRI) and one day of TMS including twelve iTBS sessions across two visits.

Official registry: https://clinicaltrials.gov/study/NCT07399496 · Medical University of South Carolina · enrollment listed as 30

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Accelerated intermittent theta-burst stimulation (iTBS) rTMS to left dorsomedial prefrontal cortex (dmPFC). The registry lists allocation as na. This single-site, open-label pilot study will measure the feasibility, tolerability, and preliminary how well it works of accelerated intermittent theta-burst stimulation (iTBS) targeting the dorsomedial prefrontal cortex (dmPFC) for apathy in individuals with Parkinson's Disease (PD).

They plan to enroll about 30 people at Charleston. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

Accelerated rTMS for Apathy in Parkinson's Disease

Interventions: Accelerated intermittent theta-burst stimulation (iTBS) rTMS to left dorsomedial prefrontal cortex (dmPFC)

Primary outcome (registry wording): TMS adherence

Who it is for (from inclusion criteria)

Ages 45 Years to 85 Years
PD Apathy Participant
Diagnosis of PD based on UK Brain Bank diagnostic criteria
Symptomatic apathy as confirmed by a total score on the Apathy Evaluation Scale by the participant or the caregiver/co-participant (AES) of ≥37
Stable on Parkinsons medications (not expected to change through the course of the treatment)
Ability to have a co-participant/caregiver who meets criteria below

Who the registry excludes

Claustrophobia or inability to lie supine in the scanner for an extended period of time
barriers to making contact between the TMS coil and the skin (e.g. braids that cannot be removed)
Contraindications to MRI/TMS safety screening: This includes but is not limited to implanted medical devices (e.g., pacemakers), metallic objects or fragments, and non-removable hair clips or piercings
Individuals with a diagnosis of bipolar disorder, schizophrenia, and/or active substance abuse disorder
Individuals with a history of seizure(s)
Acute suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) or suicide attempt in the previous year
Co-participant/Caregiver

Contact

No central phone on the registry card. Use the official listing to reach a site.

Sites listed on ClinicalTrials.gov

1 listed

Medical University of South Carolina — Charleston, South Carolina (recruiting)

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseBethesda, Maryland

Von Hippel-Lindau (VHL): Clinical Manifestations, Diagnosis, Management and Molecular Bases of Inherited Re…

We will investigate the clinical manifestations and molecular genetic defects of heritable urologic malignant disorders. Families with urologic malignancy with known or suspected genetic basis will be enrolled.

NCT00001238 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

RecruitingNot a traditional drug phaseBethesda, Maryland

Study of Systemic Lupus Erythematosus

This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE.

NCT00001372 · Official ClinicalTrials.gov record · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

RecruitingNot a traditional drug phaseWashington D.C., District of Columbia

Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics

This study is designed to explore the genetics and pathophysiology of diseases presenting with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD syndrome, and related diseases. The following individuals may be eligible for this natural history study: 1) patients with known or suspected familial Mediterranean fever, TRAPS, hyper-IgD syndrome or related disorders; 2) relatives of these patients; 3) healthy, normal volunteers 7 years of age or older.

NCT00001373 · Official ClinicalTrials.gov record · National Human Genome Research Institute (NHGRI)

FAQ about this NCT record

Is NCT07399496 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07399496?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07399496?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary