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Parkinson DiseaseNCT04255719

Unilateral GPi vs Unilateral STN DBS in the Same Patient With PD

A study testing DBS in people with Parkinson Disease and Deep Brain Stimulation, run by Ruijin Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The subthalamic nucleus (STN) and globus pallidus interna (GPi) are two main targets in the deep brain stimulation (DBS) treatment for Parkinson's disease (PD). Large randomized controlled trials, in which patients of comparable clinical and demographics were randomized to either GPi DBS or STN DBS, have demonstrated… Read more about this study

Who is it for?
Ages 55 to 75 years
What is being tested?
DBS
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteChina
Study dates
1 Mar 2020to 2 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

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 55 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with idiopathic Parkinson's disease
  • Aged between 55 and 75 years, both male and female
  • Patients who have undergone combined unilateral STN and contralateral GPi DBS for more than 6 months
  • A Hoehn-Yahr (H-Y) stage of less than 4 in the off-medication state
  • A left-extremity to right-extremity ratio of less than 0.15 on the Unified Parkinson's Disease Rating Scale part Ⅲ (UPDRS-Ⅲ) in the both off-medication and on-medication states

Who cannot join

  • History of serious psychosis
  • History of intractable epilepsy (i.e., seizures)
  • Diagnosed by the investigators that patients with severe cardiac, liver and kidney diseases, or other serious health conditions
  • Dementia (A Mini-Mental State Examination (MMSE) score of < 24), inability to comprehend the experimental protocol or voluntarily provide informed consent
  • Lack of cooperation
  • Additional reasons for exclusion at the discretion of the clinical investigator
  • Poorly controlled depression or anxiety
  • Past history of suicidal attempt

Trial locations and contacts

1 site in 1 country.

China1 site

  • Functional neurosurgery of Shanghai jiaotong university affiliated Ruijin hospital

    Shanghai, Shanghai Municipality, 200025

Other trials in China

About this study

Official title: Unilateral Pallidal vs Unilateral Subthalamic Nucleus Deep Brain Stimulation in the Same Patient With Parkinson Disease: A Randomized Controlled Trial

The subthalamic nucleus (STN) and globus pallidus interna (GPi) are two main targets in the deep brain stimulation (DBS) treatment for Parkinson's disease (PD). Large randomized controlled trials, in which patients of comparable clinical and demographics were randomized to either GPi DBS or STN DBS, have demonstrated equal effects of both targets in motor symptom improvement, the superiority of STN DBS in the medication reduction and the potential advantage of GPi DBS for cognitive, psychiatric and axial aspects. Unfortunately, in such a highly heterogeneous disease of PD, many of these randomized controlled trials didn't include sufficient subjects and thereby yielded inconsistent results. Moreover, most studies are investigating the difference between GPi and STN in different patients.

In order to address the problem, an intra-patient comparison will be made by investigating the acute turning-on effects of unilateral STN stimulation versus unilateral GPi stimulation on axial symptoms, cognition and also cardinal symptoms within each individual patient who received the treatment of combined unilateral STN and contralateral GPi DBS. Axial symptoms including gait, balance and posture, motor symptoms and cognition are comprehensively assessed under two treatment conditions.

Being tested
DBS
Medical subject headings
Parkinson Disease

What participants receive

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

  • DBSProcedure or surgery

    Unilateral DBS for treatment of patients with PD

Study groups in NCT04255719
Study groupRoleWhat they receive
Unilateral DBS of the subthalamic nucleus (STN)ExperimentalTo deliver unilateral STN DBS, bilateral stimulation will be turned off for three hours, and then turn on the unilateral STN DBS. The STN stimulation will be programmed as previous parameter configuration with optimal therapeutic benefits. Participants will be asked to complete a comprehensive set of assessments under unilateral STN stimulation in the off-medication state. 45 minutes after taking regular medication, participants need to complete the second set of assessments in the on-medication state.
Receives: Procedure: DBS
Unilateral DBS of the globus pallidus interna (GPi)ExperimentalTo deliver unilateral GPi DBS, bilateral stimulation will be turned off for three hours, and then turn on the unilateral GPi DBS. The study protocol is identical to the intervention of unilateral STN DBS but it was done on a different day.
Receives: Procedure: DBS

What is being measured

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

  1. Difference in Timed Up-and-Go (TUG) task scores between treatment conditions in the on- and off- medication states

    Timed Up-and-Go task is a well-defined objective gait measurement. The task requires an individual to stand up, walk 5 m, turn, walk back, and sit down. The time taken to complete the test is strongly correlated with the level of functional mobility. This test will be videotaped and scored by two blinded neurologists.

    Measured: 6 months

Secondary outcomes (7)

  1. Differences in total Unified Parkinson's Disease Rating Scale Part Ⅲ (UPDRS Ⅲ) scores between two treatment conditions in the on- and off- medication states

    Unified Parkinson's Disease Rating Scale Part Ⅲ measures the motor severity of Parkinson's disease. UPDRS Ⅲ score has a range of 0 (no symptoms) to 132 (severe disease symptoms).

    Measured: 6 months

  2. Differences in Burg Balance Scale (BBS) scores between two treatment conditions in the on- and off- medication states.

    Burg Balance Scale measures patients' static and dynamic balance abilities. BBS score has a range of 0 (severe balance problems) to 56 (no balance problems).

    Measured: 6 months

  3. Differences in postural angles between two treatment conditions in the on- and off- medication states.

    The measurement of postural angles is the same as the paper (Yamada et al) published in J Neurol Neurosurg Psychiatry

    Measured: 6 months

  4. Differences in Water Swallow Test (WST) scores between treatment conditions in the on- and off- medication states.

    The Water Swallow Test is frequently used in clinical practice as a functional assessment to detect dysphagia, with stage 1 indicating severe dysphagia and stage 6 indicating normal swallowing function.

    Measured: 6 months

  5. Differences in Swallowing Disturbance Questionnaire (SDQ) scores between treatment conditions in the on- and off- medication states.

    The Swallowing Disturbance Questionnaire is created as a self-rated dysphagia screening tool in PD, with a range of 0 (normal swallowing function) to 42 (severe dysphagia).

    Measured: 6 months

  6. Differences in voice parameters between treatment conditions in the on- and off- medication states.

    Voice recording at a sampling rate of 44.1 kHz using 16-bit quantification will be conducted in a sound-treated room using a microphone and a digital voice recorder with a mouth-to-microphone distance of 15 cm. The recorded voices will then be used for a composit acoustic analysis.

    Measured: 6 months

  7. Differences in Voice Handicap Index (VHI) between treatment conditions in the on- and off- medication states.

    The Voice Handicap Index is a self-administered instrument, comprising 30 items on voice-related dysfunction. VHI has a range of 0 (normal voice function) to 120 (severe voice dysfunction).

    Measured: 6 months

Timeline

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

  1. First posted5 Feb 2020
  2. Study start1 Mar 2020
  3. Primary completion27 Feb 2021
  4. Study completion2 Mar 2021

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04255719
Sponsor's protocol ID
2020 UPS study
Status last verified
Mar 2021
First submitted
2 Feb 2020
Last updated
4 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yamada K, Shinojima N, Hamasaki T, Kuratsu J. Subthalamic nucleus stimulation improves Parkinson's disease-associated camptocormia in parallel to its preoperative levodopa responsiveness. J Neurol Neurosurg Psychiatry. 2016 Jul;87(7):703-9. doi: 10.1136/jnnp-2015-310926. Epub 2015 Sep 30.

    PubMed 26424897

  • Lizarraga KJ, Luca CC, De Salles A, Gorgulho A, Lang AE, Fasano A. Asymmetric neuromodulation of motor circuits in Parkinson's disease: The role of subthalamic deep brain stimulation. Surg Neurol Int. 2017 Oct 24;8:261. doi: 10.4103/sni.sni_292_17. eCollection 2017.

    PubMed 29184712

Questions about this trial

What is this clinical trial studying?

A study testing DBS in people with Parkinson Disease and Deep Brain Stimulation, run by Ruijin Hospital at 1 site in China.

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 8 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: finished, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in Timed Up-and-Go (TUG) task scores between treatment conditions in the on- and off- medication states (time frame: 6 months). 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 NCT04255719, which also lists 2 linked publications.

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 4 Mar 2021.

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