Investigating Adaptive Deep Brain Stimulation in Parkinson's Disease Management

Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Deep Brain Stimulation

    Device

    AlphaDBS System

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: aDBSExperimental treatment 1 intervention
Group B: cDBSActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Improvement in Good On Time (GOT)

Mean improvement in GOT with cDBS, when compared with preop baseline, measured at the end of Mode 1, as assessed by a 3-day Hauser diary.

Time frame
After 3 months of follow up in cDBS as compared with preop baseline

Secondary outcomes

1

GOT difference between aDBS and cDBS

The mean difference in GOT (aDBS - cDBS) at the end of the second crossover period

Time frame
6 months of follow up (end of of the second crossover period)
2

UPDRS III score difference between aDBS and cDBS

The mean difference in UPDRS III scores (aDBS - cDBS) at the end of the second crossover period

Time frame
6 months of follow up (end of of the second crossover period)
3

PDQ-39 score difference between aDBS and cDBS

The mean difference in PDQ-39 score (aDBS - cDBS) at the end of the second crossover period

Time frame
6 months of follow up (end of of the second crossover period)
4

Subject Preference for aDBS vs. cDBS

The proportion of subjects that prefer adaptive (aDBS) mode over conventional (cDBS)mode, according to subject preference selection

Time frame
6 months of follow up (end of of the second crossover period)

Other outcomes

1

Safety Objectives

All adverse events (AEs), including serious and nonserious AEs, regardless of relationship (e.g., to study procedures, etc.), will be collected. All unanticipated events will also be collected.

Time frame
From enrollment to study exit (approximately 10-18 months)

Sponsors and contacts

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