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Recruiting NCT07399496

Accelerated TMS for Apathy in PD

No phase Interventional Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Accelerated intermittent theta-burst stimulation (iTBS) rTMS to left dorsomedial prefrontal cortex (dmPFC).
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: 45 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Accelerated Transcranial Magnetic Stimulation (TMS) for Apathy in Parkinson's Disease

Overview

This single-site, open-label pilot study will evaluate the feasibility, tolerability, and preliminary efficacy 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 six treatment visits over two weeks, receiving eight iTBS sessions per day. Outcomes include adherence, tolerability, changes in apathy (Lille Apathy Rating Scale), functional engagement, and neural target engagement assessed via resting-state fMRI and EEG. Follow-up assessments will occur at two and four weeks post-treatment.

Detailed description

This study is designed to explore a new treatment option for people with Parkinson's disease who experience apathy, which means loss of motivation or interest in daily activities. Apathy is common in Parkinson's disease and can lower quality of life, but current treatments are limited. Investigators are testing whether a non-invasive brain stimulation technique called repetitive transcranial magnetic stimulation (rTMS) is tolerable, acceptable and can be used to improve apathy in patients with Parkinson's disease. TMS delivers brief magnetic pulses to specific areas of the brain that are linked to motivation and decision-making. In this study, Investigators will use an "accelerated" version of TMS, which gives several short sessions in a single day, reducing the number of visits required. The purpose of this research is to see whether this treatment approach is feasible, tolerable and and potentially effective at treating apathy in people with Parkinson's disease. If successful, this research study will hopefully lead to a larger study in the future where the efficacy of the treatments can be studied.

Interventions

  • Device Accelerated intermittent theta-burst stimulation (iTBS) rTMS to left dorsomedial prefrontal cortex (dmPFC)
    Accelerated intermittent theta-burst stimulation (iTBS) rTMS to left dorsomedial prefrontal cortex (dmPFC) (MagVenture MagPro with cooled figure-of-eight coil; Brainsight neuronavigation; 120% rMT; 6 treatment days over \~2 weeks; 8 sessions/day; 600 pulses/session; 10-15 min inter-session interval).

Primary outcome measures

  • TMS adherence [Time frame: Day 1 through Day 14 (6 treatment days over approximately 2 weeks)]
  • Frequency and Severity of TMS-Induced Side effects (TMS tolerability and acceptability) [Time frame: Measured during each treatment day (6 days within a 2-week period)]
  • Apathy severity as measured by the Lille Apathy Rating Scale [Time frame: Baseline (Day 0), immediately post-treatment (Day 14), 2 weeks post-treatment, and 4 weeks post-treatment]
  • Target engagement (dmPFC network modulation) [Time frame: Baseline MRI/EEG assessments (Days 0-1) and post-treatment MRI/EEG assessments (Days 14-15)]
Secondary outcome measures (3)
  • Goal attainment [Time frame: Baseline (Day 0), immediately post-treatment (Day 14), 2 weeks post-treatment, and 4 weeks post-treatment]
  • Change in apathy as measured by the Dimensional Apathy Scale [Time frame: Baseline (Day 0), immediately post-treatment (Day 14), 2 weeks post-treatment, and 4 weeks post-treatment"]
  • Change in apathy-related behavior as measured by the Frontal Systems Behavior Scale [Time frame: Baseline (Day 0), immediately post-treatment (Day 14), 2 weeks post-treatment, and 4 weeks post-treatment"]

Eligibility criteria

Inclusion criteria

  • Age 45-85
  • Diagnosis of Parkinson's Disease
  • AES ≥37
  • Stable PD medications
  • Caregiver informant available

Exclusion criteria

  • MRI/TMS contraindications
  • Severe cognitive impairment (MoCA <21)
  • Psychiatric disorders (bipolar, schizophrenia, active substance use disorder)
  • Seizure history
  • Acute suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) or suicide attempt in the previous year
  • Pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Medical University of South Carolina — Charleston

Identifiers

NCT: NCT07399496 · Pro00147039

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗