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Tests treatment safety and results for Parkinson Disease
Official title Safety and Efficacy of Adaptive Deep Brain Stimulation
ClinicalTrials.gov ID: NCT04681534
What this study is testing
- What it's testing
- The aim of this study is to assess the safety and the potential efficacy of personalized Local Field Potential (LFP)-based adaptive Deep Brain Stimulation (aDBS), using the implantable pulse generator (IPG) of the "AlphaDBS" System, in Parkinson's Disease patients, chronically implanted in subthalamic nucleus (STN) for DBS.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- IPG Replacement Patients:
- Diagnosis of idiopathic PD;
- Subject is bilaterally treated with DBS in the STN using a Medtronic Activa PC or Activa RC IPG (mono-channnel or dual channel);
- DBS implant for at least 3 years and in need of battery replacement within 12 months after consent;
- Patients must be able to understand and sign the informed consent document.
You likely can't join if
- Patients with severe cognitive decline, as resulting from MoCA assessment (MoCA score \< 10);
- Patients with major psychiatric issues or any other condition that, based on the physician opinion, could interfere with the study conduct (e.g...
- Patients with any medical conditions potentially interfering with DBS battery replacement surgery (e.g. severe hypertension, active cancer, intake of...
- Need to replace or reposition the leads during the IPG replacement procedure;
- Patients with \> 10 recurrent falls experienced in the 3 months prior to consent;
- Patients that cannot tolerate an interruption of DBS stimulation for at least 30 min;
See the full eligibility criteria
Who can join
- IPG Replacement Patients:
- Diagnosis of idiopathic PD;
- Subject is bilaterally treated with DBS in the STN using a Medtronic Activa PC or Activa RC IPG (mono-channnel or dual channel);
- DBS implant for at least 3 years and in need of battery replacement within 12 months after consent;
- Patients must be able to understand and sign the informed consent document.
What rules you out
- Patients with severe cognitive decline, as resulting from MoCA assessment (MoCA score \< 10);
- Patients with major psychiatric issues or any other condition that, based on the physician opinion, could interfere with the study conduct (e.g. severe depression, psychosis, etc.);
- Patients with any medical conditions potentially interfering with DBS battery replacement surgery (e.g. severe hypertension, active cancer, intake of drugs interfering with the coagulation etc.);
- Need to replace or reposition the leads during the IPG replacement procedure;
- Patients with \> 10 recurrent falls experienced in the 3 months prior to consent;
- Patients that cannot tolerate an interruption of DBS stimulation for at least 30 min;
- Patients taking less than one levodopa dose per day;
- Patients without suitable LFPs recordings or with significant artifacts;
- Pregnant or breastfeeding women. De Novo DBS Patients: Inclusion Criteria
- Patient is ≥ 18 years old;
- Patient has been diagnosed with levodopa-responsive idiopathic Parkinson's disease for ≥ 5 years;
- The disease stage is II, III or IV according to the Hoehn and Yahr scale
- Patient has history of improvement of PD-related symptoms as a direct result of levodopa intake;
- Patient has been selected for bilateral STN or GPi DBS, independently from this study, in accordance with local standard of care DBS screening;
- Patient has been selected to receive Medtronic leads model 3389 or 37086 or Abbott directional leads model number 6170 or 6172 or 6371, independently from this study, in accordance with local standard of care for DBS;
- Patient has DBS-leads circuit integrity assessed and confirmed by impedance testing, before IPG implantation;
- MoCA score \> 26 in best medical condition;
- BDI-II score \< 17 in best medical condition;
- UPDRS-III improvement by ≥ 33% with levodopa challenge test (at approximately 90 min from the intake of the usual morning levodopa dose plus 30%);
- Patient is able to understand the study requirements and the treatment procedures and has provided written informed consent to participate;
- Patient has a responsible caregiver who will help completing the 3-day diary, provide feedback on activities of daily living (ADL), and ensure the patient complies with visit schedule;
- Patient is on stable PD-medication for one month prior surgery;
- Patient is willing and able to attend all study-required visits, complete the study procedures and attend appropriate follow up visits. Exclusion Criteria
- Patient 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...
- Patient has a history of suicide attempt or current active suicidal ideation as determined by a positive response to Item 2-5 of suicide ideation sub-scale of the Columbia Suicide Severity Rating Scale (C-SSRS);
- Patient has dementia, major depression, seizures, congestive heart failure, uncontrolled diabetes, dialysis, substance use disorders as described in DSM-V, or any other severe medical condition;
- Patient has any medical condition that could interfere with study procedures, confound the assessment of study endpoints, or prevent a proper data collection;
- Patient had confirmation of diagnosis of a terminal illness associated with survival \< 12 months;
- Patient needs repeated MRI scans;
- Patient requires diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT);
- Patient carries an electrical or electromagnetic implant (e.g., cochlear prosthesis, pacemaker, neurostimulator, etc.);
- Patient has, or plans to obtain, an implanted electrical stimulation medical device and/or an implanted medication pump (e.g., DUOPATM infusion pump) and/or is treated with a portable infusion pump;
- Patient is on anticoagulant therapy which cannot be paused for \> 5 days before IPG implant surgery;
- Patient with a history of cranial surgery including ablation procedure or any other previous neurosurgical procedure for the treatment of PD symptoms on either side of the brain;
- Patient is currently participating in another clinical study (excluding any sub-study of the present study);
- Patient is a female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception;
- Patients without suitable LFPs recordings or with significant artifacts.
The study team makes the final eligibility decision.
Where it's taking place
- Milan, Italy
- Padova, Italy
- Rome, Italy
- Turin, Italy
- Maastricht, Netherlands
- Gdansk, Poland
- Warsaw, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milan, Italy; Padova, Italy; Rome, Italy; Turin, Italy; Maastricht, Netherlands; Gdansk, Poland and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.