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Parkinson DiseaseADPNCT04616521

Asymmetric DBS for PD : A Multicenter, Prospective, Single Arm, Open Label Study

A study testing Deep brain stimulation in people with Parkinson Disease, run by Ruijin Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Deep brain stimulation (DBS) is an efficacious neurosurgical treatment for moderate-to-late stage Parkinson's disease (PD). The subthalamic nucleus (STN) and globus pallidus interna (GPi) are two targets extensively studied and used worldwide in treating PD. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson Disease
What is being tested?
Deep brain stimulation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
No sites listed yet
Study dates
1 Jan 2021to 30 Nov 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with idiopathic Parkinson's disease based on the MDS clinical diagnostic criteria for Parkinson's disease
  • Aged more than 18 years
  • Levodopa challenge test indicating a preoperative levodopa responsiveness over 24% based on MDS UPDRS-III
  • the modified Hoehn-Yahr Scale between 2 and 4 under on-medication condition
  • Compliance with written informed consent

Who cannot join

  • Atypical parkinsonian syndrome
  • History of stroke, encephalitis, neuroleptic uses, MRI scan with evidence of significant brain atrophy, lacunar infracts, or other conditions that might interfere with the intracranial surgery
  • Presence of cognitive, or psychiatric or other co-morbidities (e.g., dementia, epilepsy, cranial traumatism, brain tumor, schizophrenia, severe depression or bipolar disorder, personality disorder, etc.) that might interfere with the patient's ability to complete the evaluations or to provide informed consent
  • Presence of anatomical abnormalities in the target region
  • Clinically significant medical history or that increases pre-/post-operative complications
  • Other conditions considered by the investigators that might interfere with the surgery procedure, the follow-ups, and the interpretation of the data

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Dianyou Li, MD, PhD contact

13817864569

ldy11483@rjh.com.cn

Chencheng Zhang, MD, PhD contact

18217122884

i@cczhang.org

About this study

Official title: Asymmetric Deep Brain Stimulation for Parkinson's Disease: A Multicenter, Prospective, Single Arm, Open Label Study

Deep brain stimulation (DBS) is an efficacious neurosurgical treatment for moderate-to-late stage Parkinson's disease (PD). The subthalamic nucleus (STN) and globus pallidus interna (GPi) are two targets extensively studied and used worldwide in treating PD. Although the conventional SYMMETRIC bilateral STN and GPi DBS are shown to be effective in controlling motor symptoms such as bradykinesia, tremor, and dyskinesia, each target has its pros and cons in terms of axial symptom control, medication reduction, cognitive decline, and programming. Therefore, we speculate that an ASYMMETRIC bilateral implantation of DBS leads (i.e., combined unilateral STN and contralateral GPi DBS) may be able to bring the greatest clinical benefits to PD patients by taking advantage of both bilateral STN and GPi DBS at the same time. The preliminary retrospective study containing eight PD patients undergoing asymmetric implantation of DBS demonstrated the safety and efficacy of this treatment strategy during short-term follow-up. This multicenter, single arm, open label study aims to prospectively investigate during the long-term follow-up the safety and efficacy of asymmetric DBS for PD in terms of motor and nonmotor symptoms, medication reduction, cognitive decline, and quality of life.

Being tested
Deep brain stimulation
Keywords
deep brain stimulation, subthalamic nucleus, globus pallidus interna, asymmetric deep brain stimulation
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Deep brain stimulationProcedure or surgery

    The surgical intervention named deep brain stimulation is a well-established neurosurgical treatment for moderate-to-advanced stage PD. The targets used in this study are STN and GPi, which are widely accepted and used for symptom control in PD. The devices used for intervention have been approved by Chinese National Medical Products Administration (CFDA). The postoperative drug dosage adjustment depends on the efficacy of DBS and the judgment of the movement disorder specialist.

Study groups in NCT04616521
Study groupRoleWhat they receive
Asymmetric DBS groupExperimentalIn this arm, a one-staged combined unilateral STN and contralateral GPi DBS will be implanted into PD patients. For postural instability and gait difficulty (PIGD)-dominant patients, the GPi in the side contralateral to the leg with longer step length will be targeted. For tremor-dominant (TD) patients, the STN in the side contralateral to the body side that mostly affected will be targeted. For PD patients of mixed type, the choice of target will depend on the judgement of a multidisciplinary team based on clinical features.
Receives: Procedure: Deep brain stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale - Part III (MDS UPDRS-III)

    Score ranges from 0 to 132, higher scores mean a worse outcome.

    Measured: Followed for minimum of 7 years

Secondary outcomes (16)

  1. Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale - Part I, II, IV

    Score ranges from 0 to 128, higher scores mean a worse outcome.

    Measured: Followed for minimum of 7 years

  2. Time-Up-Go (TUG) task

    Measured: Followed for minimum of 7 years

  3. Berg Balance Scale, BBS

    Score ranges from 0 to 132, higher scores mean a better outcome.

    Measured: Followed for minimum of 7 years

  4. Gait and Falls Questionnaire, GFQ

    Score ranges from 0 to 64, higher scores mean a worse outcome.

    Measured: Followed for minimum of 7 years

  5. Montreal Cognitive Assessment (MoCA)

    Measured: Followed for minimum of 7 years

  6. Beck Depression Inventory, BDI

    Measured: Followed for minimum of 7 years

  7. Beck Anxiety Inventory, BAI

    Measured: Followed for minimum of 7 years

  8. Apathy Estimation Scale, AES

    Measured: Followed for minimum of 7 years

  9. Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Current Full, QUIP-CF

    True-or-false questions screening the obsessive-compulsive behaviors in parkinson's disease

    Measured: Followed for minimum of 7 years

  10. Epworth Sleepiness Scale, ESS

    Measured: Followed for minimum of 7 years

  11. Non-Motor Symptoms Scale, NMSS

    Score ranges from 0 to 360, higher scores mean a worseoutcome.

    Measured: Followed for minimum of 7 years

  12. Scales for Outcomes in PArkinson's disease - Autonomic, SCOPA-AUT

    Measured: Followed for minimum of 7 years

  13. 8-item Parkinson's Disease Questionnaire (PDQ-8)

    Measured: Followed for minimum of 7 years

  14. 5-Level EuroQol Five Dimensions Questionnaire, EQ-5D-5L

    Measured: Followed for minimum of 7 years

  15. Levodopa Equivalent Daily Dose, LEDD

    Measured: Followed for minimum of 7 years

  16. Adverse Events, Severe Adverse Events

    Measured: Followed for minimum of 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2020
  2. Study start1 Jan 2021 (estimated)
  3. Primary completion30 Nov 2029 (estimated)
  4. Study completion30 Nov 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04616521
Sponsor's protocol ID
Ruijin_ADP
Acronym
ADP
Status last verified
Dec 2020
First submitted
30 Oct 2020
Last updated
24 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Deep brain stimulation in people with Parkinson Disease, run by Ruijin Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dianyou Li, MD, PhD (13817864569, ldy11483@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale - Part III (MDS UPDRS-III) (time frame: Followed for minimum of 7 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04616521.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2020.

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