Parkinson Disease
Conditions
Brief summary
This is an exploratory study to preliminary assess safety and efficacy of an adaptive Deep Brain Stimulation (DBS) closed-loop method in patients with PD. The study has been designed as a double blind randomized crossover trial that uses conventional DBS as a concurrent control in PD patients in need of Implantable Pulse Generator (IPG) replacement.
Detailed description
PD patients in need of IPG replacement will be screened to identify the ones eligible for enrollment. Randomized patients will undergo 2 days of experimental sessions (i.e. one per each type of stimulation mode, cDBS and aDBS), in a well-controlled environment (i.e. during hospitalization). During each experimental session experienced neurologists will collect information on safety and efficacy endpoints.
Interventions
The investigational medical device (AlphaDBSvext) is a portable, external, dual mode stimulator that can deliver adaptive DBS or conventional DBS for the treatment of PD. In the adaptive mode, the device records Local Field Potential activity from the implanted DBS electrode and simultaneously delivers stimulation through the same electrode based on the recorded signal.
The same investigational medical device (AlphaDBSvext) is used to deliver conventional DBS for the treatment of PD. In the conventional mode it delivers constant stimulation.
Sponsors
Newronika
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of idiopathic PD; * DBS implant since at least 3 years and in need of battery replacement, defined by battery level \<25%; * Patients must be able to sign the informed consent document to participate in the clinical trial; * Patients with a suboptimal response to DBS treatment.
Exclusion criteria
* Patients with severe cognitive decline (MMSE \<25); * Patients with major psychiatric issues; * Patients with any medical condition potentially interfering with DBS battery replacement surgery; * Patients that cannot tolerate an interruption of DBS stimulation; * Patients taking only one levodopa dose per day; * Patients with no LFPs recorded from any contacts pair, during intraoperatory IPG replacement procedure; * Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Electrical Energy Delivered (TEED) to the patient | One day. | Difference in the TEED delivered to the patient in adaptive DBS versus conventional DBS mode. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of device related Adverse Events (safety and tolerability) | One day. | Number of device relate Adverse Events or abnormal vital signs. |
| Unified Parkinson's Disease Rating Scale (UPDRS) part III | One day. | Evaluation of motor symptoms through (UPDRS) part III, motor examination. The total score is computed from scores obtained on 18 items (0 best condition-4 worst condition), some considering multiple body parts. |
| Unified Dyskinesia Rating Scale (UDysRS) | One day. | Evaluation of dyskinesia through repeated clinical assessments (using UDysRS). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time off | One day. | Evaluation of time off through patient diary. |
| Local field potentials (LFP) during sleep analysis | One night. | Evaluation of LFP recording from DBS electrodes during sleep analysis. |
| DBS Impairment Scale (DBS-IS) | One day. | Self assessment through questionnaire. |
| Local field potentials (LFP) during gait analysis | Four hours. | Evaluation of LFP recording from DBS electrodes during gait analysis. |
| Local field potentials (LFP) during speech analysis | Four hours. | Evaluation of LFP recording from DBS electrodes during speech analysis. |
Countries
Italy
Outcome results
None listed