Programming Strategy of VFS for Gait Impairments in PD

NCT05905198 | Unknown

• 1 other identifier: K3438
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Variable Frequency Stimulation(VFS) is a stimulation pattern applied in Deep Brain Stimulation(DBS) therapy for Parkinson's disease(PD). Peking Union Medical College Hospital was the first centre conducting research on VFS. The studies in the past have resembled conclusion that VFS provides improvement not only in the major symptoms such as tremor and rigidity, but also in gait and balance disorder. However, the best programming strategy of VFS has not met agreement. The random-controlled double blinded crossover study is designed for participants who underwent DBS surgery in bilateral subthalamic nucleus for parkinson's disease. The investigators study several strategies on programming and observe the improvement of symptom to look for the best one. A 4-month follow-up is designed to observe a relatively long-term effectiveness of VFS. The study intends to gather more clinical evidence to guide further studies on VFS application.

Conditions

Parkinson's Disease; Deep Brain Stimulation; Gait Disorders, Neurologic

Keywords

Parkinson's disease; Deep brain stimulation; Variable frequency stimulation; Movement disorder; Freezing of gait; Crossover study

Outcome Measures

Primary Outcomes (2)

• Change from Baseline 5m-Timed Up and Go test Time Result at 2 months.

  Conduct a TUG test with 5m range setting and measure the time cost

  Baseline, 2 months

• Change from Baseline 5m-Timed Up and Go test Time Result at 4 months.

  Conduct a TUG test with 5m range setting and measure the time cost

  Baseline, 4 months

Secondary Outcomes (8)

• Change from Baseline 5m-Timed Up and Go test Step Frequency at 2 months.

  Baseline, 2 months

• Change from Baseline 5m-Timed Up and Go test Step Frequency at 4 months.

  Baseline, 4 months

• Change from Baseline 5m-Timed Up and Go test Length at 2 months.

  Baseline, 2 months

• Change from Baseline 5m-Timed Up and Go test Step Length at 4 months.

  Baseline, 4 months

• Change from Baseline 5m-Timed Up and Go test Step Variation Coefficient at 2 months.

  Baseline, 2 months

Study Arms (2)

HFS-VFS

EXPERIMENTAL

This arm will experience HFS first during the crossover, and then VFS.

Device: Programming

VFS-HFS

EXPERIMENTAL

This arm will experience VFS first during the crossover, and then HFS.

Device: Programming

Interventions

Programming DEVICE

programming the implanted DBS device to adjust the parameter and switch stimulation mode between Variable-Frequency settings and High-Frequency settings.

HFS-VFS; VFS-HFS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Idiopathic Parkinson's disease (according to the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease);
• years of age;
• Hoehn \& Yahr ≤ 3 (in best OFF-medication condition)；
• Implanted bilateral subthalamic nucleus DBS for over 1 year；
• gait Impairments in OFF-medication condition；
• High Frequency Stimulation provides significant improvement；
• in OFF-medication On-stimulation condition, capable of walking ≥ 10m.

You may not qualify if:

• mental disorder or dementia;
• Pregnant women, lactating mothers or women who are unable to take effective measures to prevent pregnancy;
• With other diseases that can affect walking distance, such as joint diseases of the lower body, spinal diseases, neuropathy, or serious heart or lung diseases;
• In severe health condition, such as diseases associated with heart or liver;
• Epilepsy;
• Lead off target;
• Unable to willingly sign Written informed Consent;
• Disagree or unable to cooperate with follow-up sessions.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Gait Disorders, Neurologic; Movement Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yi Guo, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Guo, M.D.

CONTACT

13910091280; guoyi@pumch.cn

Le Gong, Bachlor

CONTACT

13209834106; 13278884106@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: June 15, 2023
• Study Start: May 24, 2023
• Primary Completion: December 31, 2023
• Study Completion: March 1, 2024
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)