Evaluate the Effectiveness and Safety of Variable Frequency Stimulation Compared With Constant Frequency Stimulation for Patients With Idiopathic Parkinson's Disease

Not Applicable

• Conditions: Parkinson Disease
• Interventions: Procedure: Variable Frequency Stimulation

• Registration Number: NCT03053726
• Lead Sponsor: Beijing Pins Medical Co., Ltd

Brief Summary

In the VFS paradigm the stimulation frequency was set to alternate between high and low frequencies, where the frequency of stimulation or frequency combinations can be changed instantaneously according to damage of the moment rhythms. Variable frequency stimulation is a novel dynamic therapy which breaks through the existing single high-frequency stimulation paradigms. It is the world's first VFS therapy for the brain.

Detailed Description

In advanced stages of PD, motor symptoms and dyskinesia are effectively treated by deep brain stimulation (DBS) targeting the subthalamic nucleus (STN) . Traditionally, in this procedure, stimulation is set to a constant frequency electrical stimulation with the physician programming the parameters of stimulation frequency, pulse width and amplitude, and stimulated patients' brain nuclei with single frequency, single pulse width and single amplitude of the electric stimulation. Indeed, high frequency stimulation (HFS) of the STN provides consistent, long-term improvement of the cardinal signs of PD . However, the treatment effects of HFS on the axial symptoms of PD, specifically FOG can be poor often causing further impairment. While this can be alleviated by using relatively low frequency stimulation (LFS) , major concerns in the clinical application of LFS exist in regards to its duration of therapeutic benefit. Previous studies have shown that LFS of the STN improves the axial motor signs in some PD patients, but a loss of therapeutic efficacy is seen in the short term. Thereafter, patients may present increased tremor, rigidity and bradykinesia, which is often intolerable outweighing the initial benefits of LFS therapy for FOG. As such, a suitable treatment strategy for FOG remains to be established.

Based on previous findings on the relationships between stimulation frequency and movement rhythm regulation in the human body, The National Engineering Laboratory for Neuromodulation, Tsinghua University, proposes a method of variable frequency stimulation (VFS) for aiding movement.

Study Timeline

• Study First Submitted: 2017-01-22
• Study First Submitted QC: 2017-02-14
• Study First Posted: 2017-02-15
• Study Start: 2017-08-18
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-13
• Last Update Posted: 2018-03-15
• Primary Completion: 2019-09
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

1. Patients With Idiopathic Parkinson's Disease.
2. ≥18 years,both male and female
3. Patients who under deep brain stimulation
4. MMSE score ≥24
5. H-Y≥2.0 under the medicine off/ constant frequency stimulation state
6. The 14 item of UPDRS-II score ≥1
7. The 15 item of UPDRS-II score ≥2
8. Subjects had an ability to walk ≥ 10 meters independently under the medicine off/ constant frequency stimulation state

Exclusion Criteria

1. Pregnant women or breastfeeding mothers, or woman who cannot take effective measures to prevent pregnancy.
2. Presence of other diseases affecting walking distance, such as joint disease in lower body, spinal disease, neuropathy, serious heart or lung disease.
3. Diseases seriously affecting health and life, such as tumour, serious liver or kidney diseases etc.
4. Patients with epilepsy etc.
5. Presence of mental disorders or dementia.
6. Patients or their families who cannot comprehend the therapy or patients who are unable to give informed consent voluntarily.
7. Patients whom cannot cooperate well with follow-up requirements.
8. Patients excluded based on the researchers judgement for participation in the clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Constant Frequency Stimulation	Variable Frequency Stimulation	Subjects in this group received constant frequency stimulation of deep brain
Variable Frequency Stimulation	Variable Frequency Stimulation	Subjects in this group received variable frequency stimulation of deep brain stimulation

Primary Outcome Measures

Name	Time	Method
Stand-Walk-Sit	at 3 months compare to baseline	The total time of patients who complete the Stand-Walk-Sit task

Secondary Outcome Measures

Name	Time	Method
United Parkinson's Disease Rate Scale scores	at 3、6 months compare to baseline
The39-item Parkinson's Disease Questionnaire (PDQ-39) scores	at 3、6 months compare to baseline
The Freezing of Gait Questionnaire (FOG-Q) scores	at 3、6 months compare to baseline
Gait and Falls Questionnaire (GFQ) scores	at 3、6 months compare to baseline

Trial Locations

Locations (9)

General Hospital of PLA; 🇨🇳 Beijing, China

Beijing Tiantan Hospital Affiliated to Capital Medical University; 🇨🇳 Beijing, Beijing, China

Huashan hospital, Fudan university; 🇨🇳 Shanghai, China

The First Affiliated Hospital of Dalian Medical University; 🇨🇳 Dalian, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, China

Second People's Hospital of Shenzhen; 🇨🇳 Shenzhen, China

Changhai Hospital of Shanghai; 🇨🇳 Shanghai, China

The General Hospital of Shenyang Military; 🇨🇳 Shenyang, China

Nanjing Brain Hospital Affiliated to Nanjing Medical University; 🇨🇳 Nanjing, China