The purpose of the study is to demonstrate the safety and effectiveness of adaptive DBS (aDBS) for Parkinson*s disease.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To demonstrate that the proportion of aDBS subjects with *On* time without
troublesome dyskinesia during the Evaluation Phase exceeds a performance goal
of 50%.
Secondary outcome
To demonstrate decreased stimulation energy use during the aDBS Evaluation
Phase as compared with cDBS.
Background summary
Please see CIP version 5.0 page 26 section 3.1.
Study objective
The purpose of the study is to demonstrate the safety and effectiveness of
adaptive DBS (aDBS) for Parkinson*s disease.
Study design
Prospective, single-blind, randomized crossover, multi-center study of aDBS in
subjects with Parkinson*s disease.
The study is expected to be conducted at approximately 12 centers located in
the US, Europe and Canada. It is estimated that approximately 70-100 subjects
implanted with a commercially available Medtronic DBS system with Percept PC
INS will be enrolled to obtain 40 subjects for whom at least 1 aDBS mode is
acceptable and who enter the aDBS evaluation phase. Accounting for a 10%
dropout during the aDBS Evaluation Phase, a minimum of 36 subjects (at least 8
per brain target) will complete the aDBS Evaluation phase.
In addition, approximately 15 subjects implanted with a commercially available
Medtronic DBS system with Percept PC INS and SenSight system will be enrolled
in the Directional Stimulation Cohort to obtain 9 subjects for whom at least 1
aDBS mode is acceptable and who enter the aDBS Evaluation Phase. Accounting for
dropout during the aDBS Evaluation Phase, a minimum of 8 subjects will complete
the aDBS Evaluation Phase.
Study visits and/or phases include:
• Enrollment Visit: Consent, Screening
• cDBS Baseline Phase: Local Field Potential (LFP) Screening and Baseline cDBS
visits
• aDBS Setup and Adjustment Phase: aDBS Setup visit and additional optional
visits during an aDBS Adjustment period
• aDBS Evaluation Phase: One-month treatment periods in each acceptable aDBS
mode with aDBS evaluation visits at the end of each period. Randomized
crossover to the two investigational treatments in subjects for whom both aDBS
modes were acceptable and a single treatment period in those subjects for whom
only one aDBS mode was acceptable.
• Long-Term Follow Up Phase: Four visits in preferred aDBS mode for
approximately 10 months
• Extended Access Phase: Additional visits in the preferred aDBS mode every 6
months through commercial approval of aDBS
Intervention
Please see section 9.3 of CIP version 3.0
Subjects will be considered enrolled at the time they sign the informed consent
form.
Scheduled visits will include the following:
Enrollment, LFP Screening, cDBS Baseline, aDBS Setup, Randomization, aDBS
Evaluation Visit 1, aDBS Evaluation Visit 2, Long-term follow-up Visit 3,
Long-term follow-up Visit 4, Long-term follow-up Visit 5, and Long-term
follow-up Visit 6. Extended Access Visits Every 180 +/- 60 days beginning after
Visit 6 and every 6 months thereafter following the previous extended access
visit
Subjects participating in the extended access phase prior to commercial
approval of aDBS, will have visits every 6 months.
The following assessments / data will be collected during the study:
• Concomitant medications
• PDQ-39
• EQ-5D-5L
• MDS-UPRDS Parts I-IV
• Parkinson*s Disease Home Diary
• VHI
• PDSS-2
• aDBS Global Impression of Change score
• Patient preference questionnaire
• Patient satisfaction questionnaire
• Wearable data
• Programming session data, including BrainSense data
• Event markers (optional)
• Adverse Events and Device Deficiencies
Study burden and risks
The benefit of the study lies in the knowledge to be gained from the results
and the potential to improve future DBS therapies. All the potential risks have
been controlled to a level as far as possible. Based on the risk acceptance
criteria for the ADAPT-PD Trial laid out in the Study Risk Management Plan, the
study-specific residual risk is determined to be acceptable given the expected
benefits.
Endepolsdomein 5
Maastricht 6229 GW
NL
Endepolsdomein 5
Maastricht 6229 GW
NL
Listed location countries
Age
Inclusion criteria
Inclusion Criteria:
General (Primary Cohort):
1. Subject has idiopathic Parkinson*s disease
2. Subject is implanted with Percept PC (Model B35200) and Medtronic DBS leads
(Model 3387, 3389, B33005 or B33015) and extensions (Model 37085, 37086 or
B34000) bilaterally in the same target (physician confirmed), STN or GPi
3. In the opinion of the investigator, the subject responds to DBS Therapy.
4. Based on the opinion of the investigator, the subject*s cDBS parameters and
PD medications are stable and expected to remain stable from enrollment through
the end of the aDBS Evaluation phase
5. Subject is configured to ringmode monopolar or dual monopolar stimulation
using contacts 1 and/or 2 (9 and/or 10) on at least one side.
6. Subject is willing and able to attend all study-required visits and complete
the study procedures (e.g. 1-month recall questionnaires, MDS-UPDRS III)
7. Subject has the ability to understand and provide written informed consent
for participation in the study prior to the study-related procedures being
conducted
8. Subject is a male or non-pregnant female. If female of child-bearing
potential, and if sexually active, must be using, or agree to use, a
medically-acceptable method of birth control as confirmed by the investigator
9. For subjects with the SenSight system: Subject is configured to the
following stimulation rates: 55, 85, 110, 125, 145, 164 or 180 Hz (as required
for sensing/aDBS)
General (Directional Stimulation Cohort):
Subjects must meet the same inclusion criteria as the primary cohort except for
revised #2 and #5.
Revised Inclusion Criteria:
2. Subject is implanted with Percept PC (Model B35200) and Medtronic DBS leads
(Model B33005 or B33015) and extensions (Model B34000) bilaterally in the same
target (physician confirmed), STN or GPi
5. Subject is configured to directional monopolar or dual monopolar stimulation
using contacts 1 and/or 2 (9 and/or 10) .
LFP Screening
Inclusion Criteria (All Cohorts):
1. Subject has Alpha-Beta band (8-30 Hz) amplitude >= 1.2 µVp detected on either
left and/or right DBS leads on sensing channels 0-2, 0-3, or 1-3; 8-10, 8-11,
or 9-11
Exclusion criteria
Exclusion Criteria (All Cohorts)
1. Subject and/or caregiver is unable to utilize the patient programmer
2. Subject has more than one lead in each hemisphere of the brain
3. Subject has cortical leads or additional unapproved hardware implanted in
the brain
4. Subject has more than one INS
5. At enrollment, the subject*s INS has a predicted battery life of <1 year
6. Subject has Beck Depression Inventory II (BDI-II) > 25
7. Subject requires diathermy, transcranial magnetic stimulation (TMS), or
electroconvulsive therapy (ECT)
8. Subject has a metallic implant in the head, (eg, aneurysm clip, cochlear
implant)
9. Subject has, or plans to obtain, an implanted electrical stimulation medical
device anywhere in the body (eg, cardiac pacemaker, defibrillator, spinal cord
stimulator)
10. Subject has, or plans to obtain, an implanted medication pump for the
treatment of Parkinson*s disease (eg, DUOPATM infusion pump) and/or portable
infusion pump
11. Based on the opinion of the investigator, the subject has an abnormal
neurological examination that would preclude them from study participation
12. Subject is breast feeding
13. Subject is under the age of 18 years
14. Subject is currently enrolled in or plans to enroll in any concurrent drug
and/or device study that may confound the results of this study as determined
by the Medtronic study team
15. Subject is unable to use or tolerate wearable
16. Subjects with signal artifact on all 6 aDBS sense pathways (3 each on both
DBS leads) which preclude the clinician from setting thresholds
Design
Recruitment
Medical products/devices used
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04547712 |
| CCMO | NL74334.018.20 |