An interventional study of adaptive Deep Brain Stimulation and conventional Deep Brain Stimulation in Parkinson Disease, sponsored by Newronika. Terminated at 4 sites in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-11-19.
Sponsored by Newronika · Not applicable, Interventional, and Treatment
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Among 347 studies in Parkinson Disease with a site in Italy — 90 open to participants now, 108 under way, 4 of them phase 3. Parkinson Disease · Italy.
Among the 347 studies in Parkinson Disease with a site in Italy, this one is the 242nd largest by enrollment of the 244 interventional ones that give a count, is one of 20 that started in 2017, is one of 146 with no phase, and was the 123rd registered.
4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.
Browse Parkinson Disease studies →90 of the 347 studies in Parkinson Disease with a site in Italy are open now. Recruiting first, the newest first:
University Hospital Tuebingen · Sites in Italy, France, Germany and 4 more countries
Ages 35–80
Newronika · Sites in Italy
Ages 18+
University Hospital of Ferrara · Sites in Italy
Ages 18+
Universita di Verona · Sites in Italy
Ages 18+
Neuromed IRCCS · Sites in Italy
Ages 18+ · Healthy volunteers
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 749 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 64 take children under 18; 189 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
347 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 37 · Phase 3 49 · Phase 4 13
First in 2002; this study’s year is marked. 20 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 6 is below the median of 40 across 3,355 interventional studies indexed under Parkinson Disease.
Median enrollment 82 across the 244 interventional studies, 145 across the 102 observational. Of the 184 that completed or were terminated, 50 (27%) have results posted.
This tab as a report to print or save as PDF → With an account.
109 of 347 have an industry lead sponsor. The 10 most frequent:
Newronika is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Newronika has 4 studies filed under Parkinson Disease — fewer than ten, so there is no comparison to draw.
22 of the studies in Parkinson Disease with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07502066IRCCS San Camillo, Venezia, ItalyClinical Efficacy of a telerehabilItation Protocol, for the Improvement of Balance in Degenerative Neurological Diseases | 2026-12 |
| NCT07485218University of Applied Sciences and Arts of Southern SwitzerlandMultidimensional Assessment of Fatigability in Older Adults Living in Southern Switzerland and Elderly With Parkinson's Disease | 2026-12 |
| NCT07637123IRCCS San Raffaele RomaEvaluation of a Soft Elbow Exoskeleton and a Haptic Armband in Post-stroke and Parkinson's Disease Patients | 2026-12 |
| NCT07616050Marta MondelliniEvaluation of the Impact of Virtual Park on Training Motivation in Adult Patients | 2026-12 |
| NCT06814431Azienda USL Reggio Emilia - IRCCSStudy on the Incidence of Malignant Neoplasms in Patients With Parkinson's Disease and Heterozygous Mutation of the GBA Gene | 2026-12 |
Add all 22 to your calendar (.ics) → With an account.
Among the 347 studies in Parkinson Disease with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
adaptive Deep Brain Stimulation, by AlphaDBSvext.
Device: adaptive Deep Brain Stimulation
conventional Deep Brain Stimulation, by AlphaDBSvext.
Device: conventional 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.
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
Difference in the TEED delivered to the patient in adaptive DBS versus conventional DBS mode.
Time frame: One day.
Incidence of device related Adverse Events (safety and tolerability)
Number of device relate Adverse Events or abnormal vital signs.
Time frame: One day.
Unified Parkinson's Disease Rating Scale (UPDRS) part III
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.
Time frame: One day.
Unified Dyskinesia Rating Scale (UDysRS)
Evaluation of dyskinesia through repeated clinical assessments (using UDysRS).
Time frame: One day.
Time "off"
Evaluation of time "off" through patient diary.
Time frame: One day.
DBS Impairment Scale (DBS-IS)
Self assessment through questionnaire.
Time frame: One day.
Local field potentials (LFP) during gait analysis
Evaluation of LFP recording from DBS electrodes during gait analysis.
Time frame: Four hours.
Local field potentials (LFP) during speech analysis
Evaluation of LFP recording from DBS electrodes during speech analysis.
Time frame: Four hours.
Local field potentials (LFP) during sleep analysis
Evaluation of LFP recording from DBS electrodes during sleep analysis.
Time frame: One night.
Ran from Jun 2017 to primary completion in Dec 2018, 18 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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