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Not yet recruiting NCT04616521

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

No phase Interventional Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Deep brain stimulation.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Procedure Deep brain stimulation
    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 outcome measures

  • Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale - Part III (MDS UPDRS-III) [Time frame: Followed for minimum of 7 years]
Secondary outcome measures (12)
  • Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale - Part I, II, IV [Time frame: Followed for minimum of 7 years]
  • Time-Up-Go (TUG) task [Time frame: Followed for minimum of 7 years]
  • Berg Balance Scale, BBS [Time frame: Followed for minimum of 7 years]
  • Gait and Falls Questionnaire, GFQ [Time frame: Followed for minimum of 7 years]
  • Montreal Cognitive Assessment (MoCA) [Time frame: Followed for minimum of 7 years]
  • Beck Depression Inventory, BDI [Time frame: Followed for minimum of 7 years]
  • Beck Anxiety Inventory, BAI [Time frame: Followed for minimum of 7 years]
  • Apathy Estimation Scale, AES [Time frame: Followed for minimum of 7 years]
  • Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Current Full, QUIP-CF [Time frame: Followed for minimum of 7 years]
  • Epworth Sleepiness Scale, ESS [Time frame: Followed for minimum of 7 years]
  • Non-Motor Symptoms Scale, NMSS [Time frame: Followed for minimum of 7 years]
  • Scales for Outcomes in PArkinson's disease - Autonomic, SCOPA-AUT [Time frame: Followed for minimum of 7 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT04616521 · Ruijin_ADP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗