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

NCT ID: NCT03053726

Last Updated: 2018-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-18
• Study Completion Date: 2019-12-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Variable Frequency Stimulation

Subjects in this group received variable frequency stimulation of deep brain stimulation

Group Type: EXPERIMENTAL

Variable Frequency Stimulation

Intervention Type: PROCEDURE

vary the frequency of the stimulation parameter

Constant Frequency Stimulation

Subjects in this group received constant frequency stimulation of deep brain

Group Type: SHAM_COMPARATOR

Variable Frequency Stimulation

Intervention Type: PROCEDURE

vary the frequency of the stimulation parameter

Interventions

Variable Frequency Stimulation

vary the frequency of the stimulation parameter

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Pins Medical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luming Li

Role: STUDY_CHAIR

Tsinghua University

Locations

Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

General Hospital of PLA

Beijing, , China

Site Status: RECRUITING

Peking Union Medical College Hospital

Beijing, , China

Site Status: RECRUITING

The First Affiliated Hospital of Dalian Medical University

Dalian, , China

Site Status: RECRUITING

Nanjing Brain Hospital Affiliated to Nanjing Medical University

Nanjing, , China

Site Status: RECRUITING

Changhai Hospital of Shanghai

Shanghai, , China

Site Status: RECRUITING

Huashan hospital, Fudan university

Shanghai, , China

Site Status: RECRUITING

The General Hospital of Shenyang Military

Shenyang, , China

Site Status: RECRUITING

Second People's Hospital of Shenzhen

Shenzhen, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Fumin Jia

Role: CONTACT

pins_medical@163.com

010-60736388

Luming Li

Role: CONTACT

010-60736388

Facility Contacts

Jianguo Zhang, MD

Role: primary

010-67096767

Zhipei Ling, MD

Role: primary

010-66938339

Yi Guo, MD

Role: primary

010-69152530

Zhanhua Liang

Role: primary

0411-83635963

Weiguo Liu, MD

Role: primary

025-82296071

Jianmin Liu, MD

Role: primary

021-31166666

Jian Wang, MD

Role: primary

021-96567576

Yingqun Tao

Role: primary

024-28897782

Xiaodong Cai, MD

Role: primary

0755-83216006

References

Jia F, Zhang J, Wang H, Liang Z, Liu W, Wang X, Liu Y, Guo Y, Ling Z, Cai X, Wu X, Wu J, Lv W, Xu X, Zhang W, Li L. Variable- versus constant-frequency deep-brain stimulation in patients with advanced Parkinson's disease: study protocol for a randomized controlled trial. Trials. 2019 Dec 19;20(1):749. doi: 10.1186/s13063-019-3884-4.

Reference Type: DERIVED

PMID: 31856908 (View on PubMed)

Other Identifiers

PINS-025

Identifier Type: -

Identifier Source: org_study_id