Safety and Efficacy of Adaptive Deep Brain Stimulation
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04681534 |
Recruitment Status :
Recruiting
First Posted : December 23, 2020
Last Update Posted : February 7, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson Disease | Device: AlphaDBS System | Not Applicable |
The study protocol is organized in two phases: the "short-term follow-up" and the "long-term follow-up".
PD patients in need of IPG replacement will be screened for enrollment eligibility.
For the "short-term follow-up", 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). This part of the study will collect information on safety and potential efficacy endpoints as assessed by experienced neurologists. The "short term follow-up" phase will be considered complete when the endpoint assessment has been performed for all patients.
Patients, who will not experience severe side effects and who will be deemed suitable by the neurologist, will be eligible to continue in the "long-term follow-up" phase (i.e. 1 month) in their "home" environment. The "AlphaDBS" System will deliver the stimulation in aDBS or cDBS mode, for two weeks in each mode.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 15 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Double-blind Crossover Study to Evaluate the Safety and Efficacy of Adaptive Deep Brain Stimulation Delivered Through AlphaDBS System in Patients With Parkinson's Disease |
Actual Study Start Date : | January 26, 2021 |
Estimated Primary Completion Date : | September 30, 2022 |
Estimated Study Completion Date : | December 30, 2022 |

Arm | Intervention/treatment |
---|---|
Active Comparator: conventional DBS |
Device: AlphaDBS System
AlphaDBS can be programmed with two different types of stimulation: conventional DBS and adaptive DBS, that automatically adjusts the energy delivered to patient using a biosignal, local field potential (LFP), in a close loop configuration. |
Experimental: adaptive DBS |
Device: AlphaDBS System
AlphaDBS can be programmed with two different types of stimulation: conventional DBS and adaptive DBS, that automatically adjusts the energy delivered to patient using a biosignal, local field potential (LFP), in a close loop configuration. |
- Safety and tolerability of the "AlphaDBS" System, when used in cDBS and aDBS mode [ Time Frame: 1 month ]Occurrence of device related adverse events
- Change in the TEED to the patient [ Time Frame: 1 month ]Change in the Total Electrical Energy Delivered (TEED) to the patient
- PD-related motor symptoms and their fluctuations [ Time Frame: 1 month ]Evaluation of PD-related motor symptoms using the Unified Parkinson's Disease Rating Scale - UPDRS Part III.
- Dyskinesia [ Time Frame: 1 month ]Evaluation of dyskinesia and their fluctuations through repeated clinical assessments using the Unified Dyskinesia Rating Scale - UDysRS
- Dyskinesia [ Time Frame: up to 1 month ]Evaluation of the performance of a wearable accelerometer in detecting dyskinesia (compared to patient reported dyskinesia in the patient diary)
- "Time on" with and without dyskinesia [ Time Frame: 1 month ]Evaluation of "time on" with and without dyskinesia, assessed through Patient Diary
- "Time off" [ Time Frame: 1 month ]Evaluation of "time off", assessed through Patient Diary
- Patient controller usability [ Time Frame: 1 month ]Usability will be evaluated by means of a usability questionnaire
- Usability of the system for the physician [ Time Frame: 1 month ]Usability will be evaluated by means of a usability questionnaire

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.

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): NCT04681534
Contact: Costanza Conti, PhD | +39 02 84 109 381 | costanza.conti@newronika.com |
Italy | |
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Not yet recruiting |
Milan, Italy | |
Contact: Elena Pirola, MD | |
IRCCS Istituto Neurologico Carlo Besta | Not yet recruiting |
Milan, Italy | |
Contact: Roberto Eleopra, MD | |
AOU Città della Salute e della Scienza di Torino | Recruiting |
Turin, Italy | |
Contact: Michele Lanotte, MD | |
Poland | |
Copernicus Podmiot Leczniczy | Not yet recruiting |
Gdańsk, Poland | |
Contact: Witold Libionka, MD | |
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy | Recruiting |
Warsaw, Poland | |
Contact: Tomasz Mandat, MD |
Responsible Party: | Newronika |
ClinicalTrials.gov Identifier: | NCT04681534 |
Other Study ID Numbers: |
NWK_AlphaDBS_FIM_2019 |
First Posted: | December 23, 2020 Key Record Dates |
Last Update Posted: | February 7, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases |