Investigating Adaptive Deep Brain Stimulation in Parkinson's Disease Management
ConditionParkinson Disease, Idiopathic
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNewronika
About this trial
The goal of this prospective, multi-center, randomized, double-blind, crossover clinical trial is to evaluate the effectiveness and safety of adaptive DBS (aDBS) and conventional DBS (cDBS) delivered through the AlphaDBS system, in levodopa-responsive Parkinson's disease subjects. Data from previous studies conducted in Europe indicate that the use of the AlphaDBS system is safe and effective in both aDBS and cDBS modes. However, such studies suggest that aDBS may lead to more ON-time without troublesome dyskinesias in some patients. The study is designed to first demonstrate safety of effectiveness of cDBS, then to directly compare effectiveness of aDBS relative to cDBS. Subjects enrolled in the study will undergo multiple visits to assess the improvement of PD symptoms and will be randomized to Mode 1 for three months, followed by Mode 2. At the end of Mode 2, subjects will select their preferred mode, which will be maintained for 3 additional months. Subjects will complete patient diaries at different time points to evaluate their symptoms throughout the day.
Eligibility criteria
Qualifiers
Is willing and capable of signing informed consent
Is ≥18 years old
Has been diagnosed with levodopa-responsive idiopathic Parkinson's disease
Has a Hoehn and Yahr (H&Y) scale stage of II or III when OFF medication at screening
Disqualifiers
Has contraindications for DBS surgery, including any intracranial abnormality (e.g., generalized atrophy, vascular malformation, hydrocephalus, hematoma, cavernous or venous angioma, tumor or metastases, midline shift, etc.) or metallic implant (e.g., aneurysm clip, cochlear implant, etc.) or other clinically significant space-occupying lesion which in the opinion of the surgeon would impact the ability to target and place the leads or IPG
Is not on a stable dose of levodopa anti-Parkinson's disease medication for at least 2 weeks prior to Screening/Baseline assessments
Has any current major psychiatric disorder(s), such as Major Depressive Disorder, Bipolar I or II disorder, Schizophrenia, Schizoaffective Disorder, Delusional Disorder, Brief Psychotic Disorder, Obsessive-Compulsive Disorder, or any other current psychiatric condition that in the opinion of the investigator would confound the assessment of study endpoints, prevent proper data collection and/or compromise the subject's ability to participate, based on the psychiatric/psychological assessment at screening.
A history of suicide attempt within 3 years of the screening visit or current active suicidal ideation as determined by a psychiatric/psychological evaluation
Trial design
Treatments tested in this trial
- Deep Brain Stimulation
Treatment groups
104 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov