Apathy in Parkinson Disease TMS Study

Официальное название

Investigation of Non-invasive Brain Stimulation for the Treatment of Apathy

Обзор

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).

Подробное описание

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.

Вмешательства

• Устройство Transcranial Magnetic Stimulation (TMS)
  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

Первичные конечные точки

• Change in goal-directed behavior after transcranial magnetic stimulation (TMS) [Срок оценки: Immediately before stimulation and 15 minutes after stimulation.]
• Change in reward evaluation after transcranial magnetic stimulation (TMS) [Срок оценки: Immediately before stimulation and 15 minutes after stimulation.]

Вторичные конечные точки (2)

• Association between frontal midline theta EEG power and goal-oriented behavior [Срок оценки: Approximately 45 minutes before and 45 minutes after stimulation.]
• Association between frontal midline theta EEG power and reward evaluation [Срок оценки: Approximately 45 minutes before and 45 minutes after stimulation.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• UNC-Chapel Hill, Cassidy Lab — Chapel Hill

Идентификаторы

NCT: NCT06087926 · 23-1829 · K23MH132884

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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