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NCT Number: NCT04616521

Asymmetric DBS for PD : 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Deep Brain Stimulation

Procedure

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.

Primary outcomes

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

    Time frame: Followed for minimum of 7 years

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

Secondary outcomes

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

    Time frame: Followed for minimum of 7 years

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

  2. Time-Up-Go (TUG) task

    Time frame: Followed for minimum of 7 years

  3. Berg Balance Scale, BBS

    Time frame: Followed for minimum of 7 years

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

  4. Gait and Falls Questionnaire, GFQ

    Time frame: Followed for minimum of 7 years

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

  5. Montreal Cognitive Assessment (MoCA)

    Time frame: Followed for minimum of 7 years

  6. Beck Depression Inventory, BDI

    Time frame: Followed for minimum of 7 years

  7. Beck Anxiety Inventory, BAI

    Time frame: Followed for minimum of 7 years

  8. Apathy Estimation Scale, AES

    Time frame: Followed for minimum of 7 years

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

    Time frame: Followed for minimum of 7 years

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

  10. Epworth Sleepiness Scale, ESS

    Time frame: Followed for minimum of 7 years

  11. Non-Motor Symptoms Scale, NMSS

    Time frame: Followed for minimum of 7 years

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

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

    Time frame: Followed for minimum of 7 years

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

    Time frame: Followed for minimum of 7 years

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

    Time frame: Followed for minimum of 7 years

  15. Levodopa Equivalent Daily Dose, LEDD

    Time frame: Followed for minimum of 7 years

  16. Adverse Events, Severe Adverse Events

    Time frame: Followed for minimum of 7 years

Study contacts

Contact information is provided by the study sponsor or research team.

Chencheng Zhang, MD, PhD

CONTACT

[email protected]

18217122884

Dianyou Li, MD, PhD

CONTACT

[email protected]

13817864569

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University
  • Guangzhou General Hospital of Guangzhou Military Command
  • Huashan Hospital
  • Second Affiliated Hospital of Soochow University
  • Shanghai Tongji Hospital, Tongji University School of Medicine
  • The Affiliated Hospital of Xuzhou Medical University
  • The First Affiliated Hospital of Guangzhou Medical University
  • The First Affiliated Hospital with Nanjing Medical University
  • Tianjin Huanhu Hospital
  • West China Hospital

Registry information

Official study title

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

Acronym: ADP

Important dates

Study start
2021
Primary completion
2029
Study completion
2030
First posted
Nov 5, 2020
Registry last updated
Dec 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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