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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH132884 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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:
Participants will
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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation (TMS) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Immediately before stimulation and 15 minutes after stimulation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Association between frontal midline theta EEG power and subjective apathy | Degree of association between frontal midline theta EEG power and subjective apathy as measured with the Lille Apathy Rating Scale (LARS). The LARS has been validated in Parkinson Disease. It consists of a structured interview that includes 33 items. Responses are scored on a dichotomous scale. The LARS score will be investigated as an effect measure modifier in the association between performance on the S-EEfRT and frontal midline theta power. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cole Shumate | Contact | 919-445-0979 | shumatec@neurology.unc.edu | |
| Miriam Sklerov, MD | Contact | 984-974-4401 | miri@email.unc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Miriam Sklerov, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC-Chapel Hill, Cassidy Lab | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
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.
Beginning 9 and continuing for 36 months after publication.
Data will be made available to investigators who have approval from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D053609 | Lethargy |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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Participant will be blinded as to which site is being stimulated, experimental site or control site.
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| 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. | Approximately 45 minutes before and 45 minutes after stimulation. |
| Approximately 45 minutes before and 45 minutes after stimulation. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |