Apathy in Parkinson Disease TMS Study
ConditionParkinson Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-80
SponsorUniversity of North Carolina, Chapel Hill
About this trial
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. 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of idiopathic Parkinson Disease.
At least 5 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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Transcranial Magnetic Stimulation (TMS)
DeviceTranscranial 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Medial Prefrontal Cortex - Control SiteExperimental treatment 1 intervention
Group B: Control Site - Medial Prefrontal CortexExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Immediately before stimulation and 15 minutes after stimulation.2
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.
Time frame
Immediately before stimulation and 15 minutes after stimulation.Secondary outcomes
1
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.
Time frame
Approximately 45 minutes before and 45 minutes after stimulation.2
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.
Time frame
Approximately 45 minutes before and 45 minutes after stimulation.Other outcomes
1
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.
Time frame
Approximately 45 minutes before and 45 minutes after stimulation.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov