Deep Brain Stimulation for Parkinson's Disease

(ADROIT Trial)

Recruiting at 42 trial locations

Overseen By Natalie Brill, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Medical Devices

Disqualifiers: Anatomic conditions, Psychological conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the long-term safety and effectiveness of Abbott's deep brain stimulation (DBS) systems. DBS sends small electrical signals to specific brain areas to treat conditions like Parkinson's disease, essential tremor, and dystonia, a movement disorder causing muscle contractions. Individuals receiving a new DBS implant or replacing an existing device with an Abbott system may qualify. The trial aims to gather long-term data to better understand how well these systems work for various conditions. As a Phase 4 trial, this research focuses on understanding how this FDA-approved treatment benefits more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this deep brain stimulation system is safe for humans?

Research has shown that the Abbott Deep Brain Stimulation (DBS) system has been tested for safety and effectiveness. A study by Abbott found that the system is safe for patients with conditions like Parkinson's disease and essential tremor. The FDA has approved the system, indicating its safety has been reviewed for these conditions.

However, important safety notes must be considered. Patients who cannot use the system or did not benefit from a test stimulation should avoid it. Additionally, using high settings could harm brain tissue, so following the guidelines for safe use is crucial.

Real-world data also supports the safety of the Abbott DBS system, particularly when used as the manufacturer recommends. While risks exist, the system is generally safe when used correctly. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike standard treatments for neurological conditions that often rely on medications or less targeted interventions, the Abbott Deep Brain Stimulation (DBS) system offers a cutting-edge approach by directly stimulating specific areas of the brain with electrical impulses. This method allows for precise modulation of brain activity, potentially leading to better control of symptoms with fewer side effects. Researchers are particularly excited because DBS can be fine-tuned and adjusted over time to optimize results for each individual, offering a level of personalization that is not typically available with conventional therapies.

What evidence suggests that Abbott DBS is effective for Parkinson's disease and other tremors?

Studies have shown that Abbott deep brain stimulation (DBS), under investigation in this trial, can improve symptoms for people with Parkinson's disease. Specifically, patients using DBS demonstrated better results on tests measuring daily activities and overall Parkinson's symptoms. Research also indicates that DBS reduces the risk of issues such as frequent falls and mental confusion compared to medication alone. Additionally, online adjustments of DBS therapy can provide faster symptom relief than traditional in-person adjustments. Overall, strong evidence supports the effectiveness of Abbott DBS for conditions like Parkinson's and essential tremors. ^{6 7 8 9 10}

Who Is on the Research Team?

Devyani Nanduri

Principal Investigator

Abbott Medical Devices Neuromodulation

Are You a Good Fit for This Trial?

Inclusion Criteria

Subject is scheduled for a new implant or IPG device replacement surgery with a market-released Abbott DBS system within 180 days.

Subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Programming

Subjects are implanted with an Abbott DBS system and undergo initial programming

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Annual visits (in-person)

Long-term Monitoring

Continued monitoring of device- and procedure-related serious adverse events

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Abbott DBS

How Is the Trial Designed?

Group I: Deep brain stimulation Experimental Treatment 1 Intervention

Subjects implanted with an Abbott DBS system

Who Is Running the Clinical Trial?

Abbott Medical Devices

Lead Sponsor

Trials

659

Recruited

420,000+

Founded

1888

Headquarters

Abbott Park, Illinois, USA

Known For

Medical Devices Innovation

Top Products

FreeStyle Libre, MitraClip, XIENCE Stents, TECNIS IOLs

Dr. Etahn Korngold

Abbott Medical Devices

Chief Medical Officer

Medical training at Harvard Medical School and Massachusetts General Hospital

Robert B. Ford

Abbott Medical Devices

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04071847

Study Details | NCT04071847 | Abbott DBS Post-Market ... The purpose of this international study is to evaluate long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems for all indications.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7533994/

Has Deep Brain Stimulation Changed the Very Long‐Term ... We found reduced risks to develop recurrent falls and psychosis in DBS‐treated patients when compared with a group of medically managed patients who were ...

3. neuromodulation.abbott neuromodulation.abbott/us/en/healthcare-professionals/parkinsons.html

DBS Therapy for Parkinson's Disease The stimulation group showed improved Parkinson's symptoms through one year as measured by Unified Parkinson's Disease Rating Scale (UPDRS) activities of daily ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04071847/abbott-dbs-post-market-study-of-outcomes-for-indications-over-time

Abbott DBS Post-Market Study of Outcomes for Indications ... The purpose of this international study is to evaluate long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems for all indications.

5. nature.com nature.com/articles/s43856-025-00744-7

Accelerated symptom improvement in Parkinson's disease ... This study demonstrates safety and efficacy of internet-based adjustment of DBS therapy, while providing clinical benefit earlier than in-clinic ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf14/P140009S039B.pdf

fda - summary of safety and effectiveness data (ssed) The Infinity DBS System is contraindicated for patients who are unable to operate the system or who have unsuccessful test stimulation. The following procedures ...

7. neuromodulation.abbott neuromodulation.abbott/us/en/healthcare-professionals/mri-support/mri-dbs-full-systems.html

MRI Support—DBS Full Systems Do not perform an MRI scan on patients who have multiple MR Conditional neurostimulation systems for pain (multiple IPGs for pain). MRI scans may result in ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7963251/

Safety Profile of Infinity Deep Brain Stimulation Electrode ... We present real-world data on the safety of Infinity DBS placement in an interventional MR imaging suite. When manufacturer guidelines for MR imaging safety by ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf15/P150031S064B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) Abbott performed a clinical study to establish a reasonable assurance of safety and effectiveness of the Abbott Deep Brain Stimulation (DBS) System for the ...

10. abbott.com abbott.com/corpnewsroom/products-and-innovation/how-dbs-is-advancing-parkinsons-treatment.html

How DBS Is Advancing Parkinson's Treatment High stimulation outputs and charge density limits. Avoid excessive stimulation. A risk of brain tissue damage exists with parameter settings using high ...