Recruiting

iTBS

Sponsor:

Medical University of South Carolina

Code:

NCT07399496

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief summary:

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.

Conditions

Parkinson Disease

Study ID

NCT07399496

Start date

Sep 15, 2026

Status verified date

Mar, 2026

Completion date

Aug 15, 2027

Anticipated

Primary completion date

Aug 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: TMS group

participants with Parkinson's disease and clinically significant apathy receive accelerated iTBS rTMS targeting the left dorsomedial prefrontal cortex (dmPFC) using a MagVenture MagPro system with a cooled figure-of-eight coil and Brainsight neuronavigation (slightly off midline). Resting motor threshold (rMT) is determined on the first stimulation visit (PEST) and stimulation is delivered at 120% rMT. Treatment occurs on 6 days over \~2 weeks (days may be non-contiguous), with 8 sessions/day separated by 10-15 min. Each session delivers 600 pulses (50 Hz triplets; 2 s on/8 s off; \~190 s), totaling 4,800 pulses/day and 28,800 pulses overall. Coil position/angle and scalp-to-cortex distance are tracked; tolerability/acceptability (headache, pain, scalp irritation, facial twitching, fatigue, fear/anxiety) is assessed before/after sessions.

Interventions

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 measure

  • 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) ]

Central Contacts and Locations

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Emily Laramie Study Coordinator

+18437923873laramie@musc.edu

Principal Investigator:

Daniel Lench, PhD

More Information

Sponsor

Medical University of South Carolina

Last update posted

Aug 27, 2026

Last verified

Mar, 2026

Keywords

  • Neuromodulation
  • iTBS
  • Transcranial Magnetic Stimulation
  • Apathy
  • Parkinson's Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-08-27.