Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07455760
Eligibility Criteria:
Inclusion Criteria:
* Native speakers of American English
* Adults at least 18 years of age
* A clinically established diagnosis of Parkinson's disease or essential tremor
* Able to provide informed consent in the judgment of the investigator
* Treated with deep brain stimulation of the subthalamic nucleus (Parkinson's disease) or ventral intermediate nucleus of the thalamus (essential tremor)
* Stable Parkinson's disease or essential tremor medication regimen for at least one month
* Stable DBS program settings for at least one month
* Nominal DBS system function, including normal impedances at therapeutic DBS contacts, and adequate battery life or adequate IPG charging status for therapy
* For DBS sensing, implanted with Medtronic Percept PC or Percept RC implantable pulse generator
* Corrected vision adequate to easily read text presented during speech motor task
Exclusion Criteria:
* Cognitive impairment (Montreal Cognitive Assessment (MoCA; Nesreddine et al., 2005) score \< 25) or active psychotic or behavioral symptoms that would, in the judgment of the investigator, preclude proper participation in the study
* Hearing impairment that interferes with accurate perception of the speech motor learning stimulus (25dB hearing level threshold at 500, 1k, 2k, and 4kHz frequencies)
* Language impairment (aphasia) or speech articulation impairment (dysarthria) that precludes performance of the speech motor learning task
* Neurological disorder that interferes with speech motor learning
* Inability to tolerate symptoms when DBS is off
* Orthodontia or atypical oral structure (e.g., cleft palate) that interferes with speech
* Pregnancy
* For participants in the sub-syllabic sequence learning study (Study C.2.1), experience with the following languages: Hebrew, Polish, Lithuanian, Romanian, Georgian, Tepehua, Hungarian, and Pima
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07455760
Study Brief:
Protocol Section:
NCT07455760