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Parkinson DiseaseNCT05314322

Deep Brain Stimulation on Dual-task Gait Performance in PD

A study testing Deep brain stimulation with high frequency and Deep brain stimulation with low frequency in people with Parkinson Disease, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Parkinson's disease (PD) is the second most common neurodegenerative disease after Alzheimer's disease. Motor symptoms include rigidity, bradykinesia, tremor, and postural instability, these motor symptoms can cause gait dysfunction. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
Deep brain stimulation with high frequency and Deep brain stimulation with low frequency
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteTaiwan
Study dates
1 Apr 2022to 31 Jul 2025
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 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Idiopathic PD
  • Age: 50~80 yrs old
  • Hoehn and Yahr stage ≤ IV after DBS operation
  • Implanted DBS system for at least 6 months
  • MMSE ≥24

Who cannot join

  • Other neurological disorders
  • Any major systemic, psychiatric, visual, and musculoskeletal disturbances or other causes of walking inability

Trial locations and contacts

1 site in 1 country.

Yea-Ru Yang, PhD contact

+886-2-2876-7279

yryang@nycu.edu.tw

Taiwan1 site

  • Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University

    Taipei, 112

Other trials in Taiwan

About this study

Official title: The Impacts of Deep Brain Stimulation on Dual-task Gait Performance in Parkinson's Disease: Focusing on Long-term Outcome and the Effects of Stimulation Modes

Parkinson's disease (PD) is the second most common neurodegenerative disease after Alzheimer's disease. Motor symptoms include rigidity, bradykinesia, tremor, and postural instability, these motor symptoms can cause gait dysfunction. Non-motor symptoms include depression, dysarthria, cognitive disability, and sleep disturbance. Although these symptoms can be improved through drug treatment, when the course of PD reaches the middle to late stage, it will still face the situation of weakened drug efficacy and the drug side effects increased. When medication can no longer adequately control the motor symptoms of PD, deep brain stimulation (DBS) becomes a powerful option. DBS is a surgical treatment that involves implanting one or more electrodes into specific areas of the brain, which deliver electrical stimulation to regulate or destroy abnormal neural signal patterns in the target area. The effect of DBS has been proven whether it is in improving motor-related symptoms or non-motor-related symptoms, but there are still some areas that have not been compared before and after the surgery, such as: gait variability, executive functions and dual-task walking. In addition, the parameters of electrical stimulation for DBS will also affect the clinical characteristics of patients. Due to the large difference between individual cases, the recommendation of the electrical stimulation frequency still not be established. Therefore, the influence of DBS and its parameters on the symptoms of PD is a topic worthy of discussion. Purposes: (1) To investigate the long-term effects of DBS on the symptoms of PD. (2) To investigate the effects of DBS stimulation frequencies on walking performance and executive function in individuals with PD.

Being tested
Deep brain stimulation with high frequency, Deep brain stimulation with low frequency
Keywords
Deep brain stimulation, Dual-task walking, Executive function
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 stimulation with high frequencyProcedure or surgery

    Deep brain stimulation implanted at the patients' Substantia Nigra

  • Deep brain stimulation with low frequencyProcedure or surgery

    Deep brain stimulation implanted at the patients' Substantia Nigra

Study groups in NCT05314322
Study groupRoleWhat they receive
High frequency groupExperimentalDeep brain stimulation's parameter: Frequency adjusted to 130Hz, with other parameters fixed
Receives: Procedure: Deep brain stimulation with high frequency
Low frequency groupExperimentalDeep brain stimulation's parameter: Frequency adjusted to 60Hz, with other parameters fixed
Receives: Procedure: Deep brain stimulation with low frequency

What is being measured

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

  1. Dual-task gait performance: Stride length

    Using the OPTO gait system to evaluate stride length

    Measured: Three days after frequency adjustment

  2. Dual-task gait performance: Double limb support time

    Using the OPTO gait system to evaluate double limb support time

    Measured: Three days after frequency adjustment

  3. Executive function - Inhibition control

    Using the Stroop test to evaluate inhibition control

    Measured: Three days after frequency adjustment

  4. Executive function - Shifting attention

    Using the Trail Making Test to evaluate shifting attention

    Measured: Three days after frequency adjustment

  5. Executive function - Working memory

    Using the Digit span test to evaluate working memory

    Measured: Three days after frequency adjustment

  6. Cognitive function

    Using the Montreal Cognitive Assessment (MoCA) to evaluate cognitive function

    Measured: Every 6-month up to 2 years

  7. Non-motor symptoms

    Using the Non-motor Symptoms Scale (NMSS) to non-motor symptoms

    Measured: Every 6-month up to 2 years

Secondary outcomes (10)

  1. Usual gait performance: Stride length

    Using the OPTO gait system to evaluate stride length

    Measured: Three days after frequency adjustment

  2. Usual gait performance: Double limb support time

    Using the OPTO gait system to evaluate double limb support time

    Measured: Three days after frequency adjustment

  3. Brain activity: Prefrontal Cortex

    Using Functional near-infrared spectroscopy (fNIRS) to evaluate brain activity of Prefrontal Cortex with the formula: Hb diff=HbO-HbR

    Measured: Three days after frequency adjustment

  4. Brain activity: Supplementary Motor Cortex

    Using Functional near-infrared spectroscopy (fNIRS) to evaluate brain activity of Supplementary Motor Area with the formula: Hb diff=HbO-HbR

    Measured: Three days after frequency adjustment

  5. Brain activity: Premotor Cortex

    Using Functional near-infrared spectroscopy (fNIRS) to evaluate brain activity of Premotor Cortex with the formula: Hb diff=HbO-HbR

    Measured: Three days after frequency adjustment

  6. Functional activity: Gait and balance performance

    Using the Timed up and go test to evaluate functional activity

    Measured: Every 6-month up to 2 years

  7. Functional activity: Lower limb function

    Using the 30s Chair Stand Test to evaluate functional activity

    Measured: Every 6-month up to 2 years

  8. Balance performance

    Using the Mini-BEST test to evaluate balance performance

    Measured: Every 6-month up to 2 years

  9. Motor symptoms

    Using the Unified Parkinson's Disease Rating Scale (UPDRS) part 3 to evaluate motor symptoms

    Measured: Every 6-month up to 2 years

  10. Parkinson's Disease patients' Quality of life

    Using the Parkinson's Disease Questionnaire (PDQ-39) evaluate quality of life

    Measured: Every 6-month up to 2 years

Timeline

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

  1. First posted6 Apr 2022
  2. Study start1 Apr 2022 (estimated)
  3. Primary completion31 Jul 2025 (estimated)
  4. Study completion31 Jul 2025 (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
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05314322
Sponsor's protocol ID
2022-02-016A
Status last verified
Mar 2022
First submitted
16 Mar 2022
Last updated
6 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Deep brain stimulation with high frequency and Deep brain stimulation with low frequency in people with Parkinson Disease, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.

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 2 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: status not confirmed, as of the sponsor's last update on 6 Apr 2022. 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 Taiwan. 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?

Results are not available in the source record.

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

Contact Yea-Ru Yang, PhD (+886-2-2876-7279, yryang@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dual-task gait performance: Stride length (time frame: Three days after frequency adjustment). The study lists 7 primary outcomes in all. 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 NCT05314322.

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 6 Apr 2022.

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