Parkinson DiseasePDTMSAPATHYNCT06087926
Apathy in Parkinson Disease TMS Study
A study testing Transcranial Magnetic Stimulation (TMS) in people with Parkinson Disease, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The goal of this clinical trial is to develop non-invasive brain stimulation targets for the treatment of apathy, or motivation problems, in Parkinson Disease. The main questions the study aims to answer are: 1. Does transcranial magnetic stimulation change effort task performance in Parkinson's Disease patients? 2. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Transcranial Magnetic Stimulation (TMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic Parkinson Disease.
- At least 4 years of symptoms.
- On dopaminergic medication for Parkinson Disease.
- Stable on dopaminergic medication and other medications which may influence apathy (such as selective serotonin re-uptake inhibitors, stimulant medications) for at least 4 weeks prior to first study visit and remain stable throughout the study period.
- Hospital's study-specific informed consent must be obtained.
- Must have capacity to provide informed consent in English.
- For female participants, confirmation that they have not had a menstrual period in over 12 months, or that they will use an effective form of contraception during the study.
Who cannot join
- Inability to provide informed consent.
- Inability to perform effort task (determined during the titration session).
- Presence of dementia (Montreal Cognitive Assessment (MoCA) score < 21).
- History of epilepsy or brain surgery.
- Severe tremor or dyskinesia that would interfere with EEG (determined by the PI).
- Patients with clinically significant medical or neurological conditions which may be an alternative cause of parkinsonism such as repeated brain injury, anti-dopaminergic medications, anoxic brain injury, or significant basal ganglia strokes.
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- Presence of other known central nervous system disease that may interfere with performance or interpretation of EEG or TMS.
- Presence of any implanted metal devices including, but not limited to, pacemakers, deep brain stimulators, vagal nerve stimulators, bladder stimulators, or cochlear implants.
- Presence of medical contraindications to TMS such as implanted stimulators, history of mania or bipolar disorder, history of epilepsy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UNC-Chapel Hill, Cassidy Lab
Chapel Hill, North Carolina, 27599
Cole Shumate, BA, 919-445-0979, shumatec@neurology.unc.edu
Miriam Sklerov, MD
About this study
Official title: Investigation of Non-invasive Brain Stimulation for the Treatment of Apathy
The goal of this clinical trial is to develop non-invasive brain stimulation targets for the treatment of apathy, or motivation problems, in Parkinson Disease.
The main questions the study aims to answer are:
Read more
- Does transcranial magnetic stimulation change effort task performance in Parkinson's Disease patients?
- Is there a link between brain signals and apathy?
Participants will
- complete questionnaires and assessments
- perform an effort task
- have their brain activity recorded (EEG)
- receive non-invasive brain stimulation (TMS)
Researchers will compare two stimulation locations (experimental site and control site) to see if TMS of the experimental site has an effect on apathy. Participants will receive stimulation of both sites (during separate visits).
Read the detailed description
Participants will be asked to come for 3 study visits.
During visit 1, after being informed about the study and potential risks, all patients giving written informed consent will undergo a brief cognitive assessment, a movement examination, and answer questionnaires. Additionally, the individual motor threshold will be determined for each participant. Visit 1 will take 2-3 hours.
Visits 2 and 3 will involve:
- completing questionnaires,
- performing a task where fictitious rewards can be earned by squeezing a dynamometer,
- recording brain activity with an electroencephalogram (EEG), and
- receiving transcranial magnetic stimulation (TMS). Visits 2 and 3 will take approximately 3 hours each and will be separated from each other by at least 3 weeks.
- Conditions
- Parkinson Disease
- Being tested
- Transcranial Magnetic Stimulation (TMS)
- Keywords
- Apathy, Motivation
- Medical subject headings
- Parkinson Disease, Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS)Device
Also called Intermittent Theta-Burst Stimulation (iTBS)
Transcranial magnetic stimulation (or TMS) is a non-invasive form of brain stimulation in which a magnetic pulse is applied directly to the scalp. TMS is FDA approved for the treatment of depression and other neuropsychiatric disorders and is regularly used in neurologic and psychiatric research.
ITBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatment lasts approximately 3 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Medial Prefrontal Cortex - Control Site | Experimental | Participants first undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3-week washout period, participants then undergo transcranial magnetic stimulation to the control site. Receives: Device: Transcranial Magnetic Stimulation (TMS) |
| Control Site - Medial Prefrontal Cortex | Experimental | Participants first undergo transcranial magnetic stimulation to the control site. After a 3-week washout period, participants then undergo transcranial magnetic stimulation to the medial prefrontal cortex. Receives: Device: Transcranial Magnetic Stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in goal-directed behavior after transcranial magnetic stimulation (TMS)
Differences in the degree of change in goal-directed behavior after brain stimulation at each site (medial prefrontal cortex or control site).
Goal-directed behavior will be determined using the streamlined version of the Expenditure of Effort for Reward Task (S-EEfRT). In the S-EEfRT, participants choose to complete either a "Hard" task or an "Easy" task for variable monetary incentives.
Measured: Immediately before stimulation and 15 minutes after stimulation.
Change in reward evaluation after transcranial magnetic stimulation (TMS)
Differences in the degree of change in reward evaluation after brain stimulation at each site (medial prefrontal cortex or control site).
Reward evaluation will be determined using the streamlined version of the Expenditure of Effort for Reward Task (S-EEfRT). In the S-EEfRT, participants choose to complete either a "Hard" task or an "Easy" task for variable monetary incentives.
Measured: Immediately before stimulation and 15 minutes after stimulation.
Secondary outcomes (2)
Association between frontal midline theta EEG power and goal-oriented behavior
Degree of association between frontal midline theta EEG power and goal-oriented behavior.
Goal-directed behavior will be determined using the streamlined version of the Expenditure of Effort for Reward Task (S-EEfRT). In the S-EEfRT, participants choose to complete either a "Hard" task or an "Easy" task for variable monetary incentives.
Measured: Approximately 45 minutes before and 45 minutes after stimulation.
Association between frontal midline theta EEG power and reward evaluation
Degree of association between frontal midline theta EEG power and reward evaluation.
Reward evaluation will be determined using the streamlined version of the Expenditure of Effort for Reward Task (S-EEfRT). In the S-EEfRT, participants choose to complete either a "Hard" task or an "Easy" task for variable monetary incentives.
Measured: Approximately 45 minutes before and 45 minutes after stimulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 May 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Miriam Sklerov, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087926
- Sponsor's protocol ID
- 23-1829
- Other IDs
- K23MH132884
- Acronym
- PDTMSAPATHY
- Status last verified
- May 2026
- First submitted
- 11 Oct 2023
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Non-invasive Brain Stimulation for the Treatment of Apathy
- ClinicalTrials.gov ID
- NCT06087926
- Acronym / sponsor ID
- PDTMSAPATHY / 23-1829
- Conditions
- Parkinson Disease
- Keywords
- Apathy, Motivation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to develop non-invasive brain stimulation targets for the treatment of apathy, or motivation problems, in Parkinson Disease.
The main questions the study aims to answer are:
- Does transcranial magnetic stimulation change effort task performance in Parkinson's Disease patients?
- Is there a link between brain signals and apathy?
Participants will
- complete questionnaires and assessments
- perform an effort task
- have their brain activity recorded (EEG)
- receive non-invasive brain stimulation (TMS)
Researchers will compare two stimulation locations (experimental site and control site) to see if TMS of the experimental site has an effect on apathy. Participants will receive stimulation of both sites (during separate visits).
Detailed description
Participants will be asked to come for 3 study visits.
During visit 1, after being informed about the study and potential risks, all patients giving written informed consent will undergo a brief cognitive assessment, a movement examination, and answer questionnaires. Additionally, the individual motor threshold will be determined for each participant. Visit 1 will take 2-3 hours.
Visits 2 and 3 will involve:
- completing questionnaires,
- performing a task where fictitious rewards can be earned by squeezing a dynamometer,
- recording brain activity with an electroencephalogram (EEG), and
- receiving transcranial magnetic stimulation (TMS). Visits 2 and 3 will take approximately 3 hours each and will be separated from each other by at least 3 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medial Prefrontal Cortex - Control Site | Experimental | Device: Transcranial Magnetic Stimulation (TMS)Participants first undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3-week washout period, participants then undergo transcranial magnetic stimulation to the control site. |
| Control Site - Medial Prefrontal Cortex | Experimental | Device: Transcranial Magnetic Stimulation (TMS)Participants first undergo transcranial magnetic stimulation to the control site. After a 3-week washout period, participants then undergo transcranial magnetic stimulation to the medial prefrontal cortex. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of idiopathic Parkinson Disease.
- At least 4 years of symptoms.
- On dopaminergic medication for Parkinson Disease.
- Stable on dopaminergic medication and other medications which may influence apathy (such as selective serotonin re-uptake inhibitors, stimulant medications) for at least 4 weeks prior to first study visit and remain stable throughout the study period.
- Hospital's study-specific informed consent must be obtained.
Key exclusion criteria (9 listed)
- Inability to provide informed consent.
- Inability to perform effort task (determined during the titration session).
- Presence of dementia (Montreal Cognitive Assessment (MoCA) score < 21).
- History of epilepsy or brain surgery.
- Severe tremor or dyskinesia that would interfere with EEG (determined by the PI).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS)Also: Intermittent Theta-Burst Stimulation (iTBS)Transcranial magnetic stimulation (or TMS) is a non-invasive form of brain stimulation in which a magnetic pulse is applied directly to the scalp. TMS is FDA approved for the treatment of depression and other neuropsychiatric disorders and is regularly used in neurologic and psychiatric research. ITBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatment lasts approximately 3 minutes. | Device | Control Site - Medial Prefrontal Cortex, Medial Prefrontal Cortex - Control Site |
Primary outcome
Change in goal-directed behavior after transcranial magnetic stimulation (TMS)
Time frame: Immediately before stimulation and 15 minutes after stimulation.
Differences in the degree of change in goal-directed behavior after brain stimulation at each site (medial prefrontal cortex or control site). Goal-directed behavior will be determined using the streamlined version of the Expenditure of Effort for Reward Task (S-EEfRT). In the S-EEfRT, participants choose to complete either a "Hard" task or an "Easy" task for variable monetary incentives.
Change in reward evaluation after transcranial magnetic stimulation (TMS)
Time frame: Immediately before stimulation and 15 minutes after stimulation.
Differences in the degree of change in reward evaluation after brain stimulation at each site (medial prefrontal cortex or control site). Reward evaluation will be determined using the streamlined version of the Expenditure of Effort for Reward Task (S-EEfRT). In the S-EEfRT, participants choose to complete either a "Hard" task or an "Easy" task for variable monetary incentives.
2 secondary outcomes
Association between frontal midline theta EEG power and goal-oriented behavior
Time frame: Approximately 45 minutes before and 45 minutes after stimulation.
Association between frontal midline theta EEG power and reward evaluation
Time frame: Approximately 45 minutes before and 45 minutes after stimulation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miriam Sklerov, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (TMS) in people with Parkinson Disease, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cole Shumate (919-445-0979, shumatec@neurology.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in goal-directed behavior after transcranial magnetic stimulation (TMS) (time frame: Immediately before stimulation and 15 minutes after stimulation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.