Accelerated brain stimulation for apathy in Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-site, open-label pilot enrolls 15 people with Parkinson's disease and clinically significant apathy to receive accelerated intermittent theta-burst stimulation (iTBS) targeting the dorsomedial prefrontal cortex. Participants will complete six treatment visits over two weeks with eight short iTBS sessions delivered per day. Primary outcomes include feasibility and tolerability, with clinical measures of apathy (Lille Apathy Rating Scale), functional engagement, and neural target engagement using resting-state fMRI and EEG. Follow-up assessments occur at two and four weeks after the treatment course to capture short-term changes.

Why it matters

Who can join: the full rules

PD Apathy Participant

Inclusion criteria:

1. 45-85 years of age
2. Diagnosis of PD based on UK Brain Bank diagnostic criteria
3. Symptomatic apathy as confirmed by a total score on the Apathy Evaluation Scale by the participant or the caregiver/co-participant (AES) of ≥37
4. Stable on Parkinsons medications (not expected to change through the course of the treatment)
5. Ability to have a co-participant/caregiver who meets criteria below.

Exclusion Criteria:

1. Claustrophobia or inability to lie supine in the scanner for an extended period of time
2. barriers to making contact between the TMS coil and the skin (e.g. braids that cannot be removed)
3. 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.
4. Individuals with a diagnosis of bipolar disorder, schizophrenia, and/or active substance abuse disorder.
5. Pregnancy
6. Individuals with a history of seizure(s).
7. Presence of cognitive impairment or dementia that would impact participant's capacity to give informed consent or ability to participate in study procedures as indicated by chart review and/or measured by the MoCA (\<21)
8. Acute suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) or suicide attempt in the previous year

Co-participant/Caregiver

Inclusion Criteria:

1. 18 years of age or older
2. Is a reliable informant who has at least weekly contact with the participant and can speak to the participant's apathy and everyday functioning.

Exclusion criteria:

1\) Unable to engage with study procedures in which co-participant input is needed.

PD Control Group

Inclusion Criteria:

1. Age matched to participants in the PD Apathy group (45 to 85 years of age)
2. Diagnosis of PD based on UK Brain Bank diagnostic criteria \[17\]
3. Stable on Parkinsons medications (not expected to change through the course of the study)

Exclusion Criteria:

1. Symptomatic apathy as confirmed by a total score on the Apathy Evaluation Scale by the participant or the caregiver/co-participant (AES) of ≥37
2. Claustrophobia or inability to lie supine in the scanner for an extended period of time
3. Contraindications to MRI 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
4. Neuropsychiatric disorder diagnosis
5. Uncorrected visual or hearing impairments, as indicated by self-report
6. Pregnancy
7. Presence of cognitive impairment or dementia that would impact participant's capacity to give informed consent or ability to participate in study procedures as indicated by chart review and/or measured by the MoCA (\<21)

Co-participant/Caregiver

Inclusion Criteria:

3\) 18 years of age or older 4) Is a reliable informant who has at least weekly contact with the participant and can speak to the participant's mood and everyday functioning.

Exclusion criteria:

2\) Unable to engage with study procedures in which co-participant input is needed.

Where it's running

• Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting

Study contacts

• Principal investigator: Daniel Lench — Medical University of South Carolina

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.