Safety and Efficacy of Adaptive DBS Vs Conventional DBS in Patients With Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT03422757|
Recruitment Status : Terminated (Company strategic decision)
First Posted : February 6, 2018
Last Update Posted : November 19, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Device: adaptive Deep Brain Stimulation Device: conventional Deep Brain Stimulation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Double Blind, Crossover Study to Evaluate Safety and Efficacy of an Adaptive Deep Brain Stimulation Closed-loop Method Compared With Conventional Deep Brain Stimulation in Patients With Parkinson's Disease|
|Actual Study Start Date :||June 1, 2017|
|Actual Primary Completion Date :||December 30, 2018|
|Actual Study Completion Date :||December 30, 2018|
Experimental: adaptive DBS
adaptive Deep Brain Stimulation, by AlphaDBSvext.
Device: adaptive Deep Brain Stimulation
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.
Active Comparator: conventional DBS
conventional Deep Brain Stimulation, by AlphaDBSvext.
Device: conventional Deep Brain Stimulation
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.
- Total Electrical Energy Delivered (TEED) to the patient [ Time Frame: One day. ]Difference in the TEED delivered to the patient in adaptive DBS versus conventional DBS mode.
- Incidence of device related Adverse Events (safety and tolerability) [ Time Frame: One day. ]Number of device relate Adverse Events or abnormal vital signs.
- Unified Parkinson's Disease Rating Scale (UPDRS) part III [ Time Frame: 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) [ Time Frame: One day. ]Evaluation of dyskinesia through repeated clinical assessments (using UDysRS).
- Time "off" [ Time Frame: One day. ]Evaluation of time "off" through patient diary.
- DBS Impairment Scale (DBS-IS) [ Time Frame: One day. ]Self assessment through questionnaire.
- Local field potentials (LFP) during gait analysis [ Time Frame: Four hours. ]Evaluation of LFP recording from DBS electrodes during gait analysis.
- Local field potentials (LFP) during speech analysis [ Time Frame: Four hours. ]Evaluation of LFP recording from DBS electrodes during speech analysis.
- Local field potentials (LFP) during sleep analysis [ Time Frame: One night. ]Evaluation of LFP recording from DBS electrodes during sleep analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422757
|Centro Parkinson e Disturbi del Movimento ASST G.Pini- CTO|
|Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico|
|IRCCS Istituto Ortopedico Galeazzi|
|Fondazione Istituto Neurologico Nazionale Casimiro Mondino|