MRI Compatible and Long-term LFP Recordable Deep Brain Stimulation on PD Patients

Evaluate the Safety and Effectiveness of 3T MRI Compatible and Long-term LFP Recordable Deep Brain Stimulation on PD Patients

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02937727

Enrollment

Registered

2016-10-19

Start date

2016-11-30

Completion date

2018-03-31

Last updated

2017-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Parkinson Patients

Brief summary

Deep Brain Stimulation represents the golden standard for surgical treatment of Parkinson's disease (PD), but it is not optimally effective for controlling every motor sign and adverse events are not so infrequent. Therefore,other approaches should be considered. New Approaches in MRI at 3T and long-term local field potential (LFP) recording are very important to target subthalamic nucleus (STN) and understand mechanisms of DBS on Parkinson Patients. This study aims at evaluating the safety and effectiveness of 3T MRI Compatible and LFP recordable deep brain stimulation on PD patients. The Chronically LFP recording using G106R is for two goals: 1) Evaluate the performance of long-term recordable neural simulation. 2) Study long-term clinical and electrophysiology effects of deep brain stimulation on STN.

Interventions

DEVICE3T MRI compatible and LFP recordable G106R of Beijing Pins medical.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Age ≥18，≤75，idiopathic Parkinson's disease，both male and female 2. MMSE score ≥24 3. H-Y score ≥2.0 on the medicine off situation 4. UPDRS-III score≥30 on the medicine off situation 5. The duration of this disease ≥5 years 6. Ability to provide informed consent as determined by preoperative neuropsychological assessment 7. History of appropriate response to dopaminergic medication, with at least a 30% improvement in motor UPDRS with L-DOPA by history or in-clinic testing, for the PD patients 8. Excellent responsiveness to levodopa 9. ≥6h in medicine off state

Exclusion criteria

1. Lack of ability to provide informed consent as determined by preoperative neuropsychological assessment 2. Otherwise not eligible for DBS surgery, for example known inability to undergo anesthesia 3. Hydrocephalus，brain atrophy，cerebral infarction ，cerebralvascular diseases 4. Patients who are unable to follow verbal instructions 5. Other severe pathological chronic condition that might confound treatment effects or interpretation of the data

Design outcomes

Primary

Measure	Time frame
UPDRS part III	1 month,3 months, 6 months and 12months
Local Field Potential Recordings using G106R	1 month,3 months, 6 months and 12months

Secondary

Measure	Time frame	Description
UPDRS part III	1, 3 months of stimulation	—
UPDRS part II	1, 3 months stimulation	—
Levodopa Equivalent Dose	1, 3 months stimulation	Drug Therapy are definied as levodopa equivalent dose,which is devodopa containing or dopamine agonist containing medications
Local Field Potential Recordings using G106R	1 month, 3 months	—

Countries

China

Contacts

Primary ContactFumin Jia, PhD

010-60736388

Backup ContactLuming Li, PhD