Neural and Kinematic Features of Freezing of Gait for Adaptive Neurostimulation

NCT03180515 | Completed Results DMC FDA Device

• 1 other identifier: 1R21NS096398
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Continuous deep brain stimulation (cDBS) is an established therapy for the major motor signs in Parkinson's disease, however some patients find that it does not adequately treat their freezing of gait (FOG). Currently, cDBS is limited to "open-loop" stimulation,without real-time adjustment to the patient's state of activity, fluctuations and types of motor symptoms, medication dosages, or neural markers of the disease. The purpose of this study is to determine if an adaptive DBS system,responding to patient specific, clinically relevant neural or kinematic feedback related to FOG, is more effective than continuous DBS on the motor Unified Parkinson's Disease Rating Scale (UPDRS III) and gait measures of PD.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Related to aDBS

  Safety, tolerability and feasibility of aDBS

  30 min - 2 hours

Secondary Outcomes (9)

• Aim 1: Alpha Power

  30 minutes

• Aim 1: Beta Power

  30 minutes

• Aim 1: Alpha Sample Entropy

  30 minutes

• Aim 1: Beta Sample Entropy

  30 minutes

• Aim 2: Asymmetry

  30 minutes

Study Arms (1)

Activa PC+S Neurostimulator

EXPERIMENTAL

All patients will complete motor testing on both continuous DBS and adaptive DBS during a study visit. The UPDRS rater and the patient will be blind to which type of stimulation they are on.

Device: Activa PC+S Neurostimulator

Interventions

Activa PC+S Neurostimulator DEVICE

Activa PC+S Neurostimulator is approved for both aDBS and cDBS paradigms.

Also known as: adaptive deep brain stimulation (aDBS), continuous deep brain stimulation (cDBS)

Activa PC+S Neurostimulator

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of idiopathic Parkinson's disease, with bilateral symptoms at Hoehn and Yahr Stage greater than or equal to II.
• Documented improvement in motor signs on versus off dopaminergic medication, with a change in the Unified Parkinson's Disease Rating Scale motor (UPDRS III) score of \>= 30% off to on medication.
• The presence of complications of medication such as wearing off signs,fluctuating responses and/or dyskinesias, and/or medication refractory tremor,and/or impairment in the quality of life on or off medication due to these factors.
• Subjects should be on stable doses of medications, which should remain unchanged until the DBS system is activated. After the DBS system is optimized(during which time the overall medication dose may be reduced to avoid discomfort and complications such as dyskinesias) the medication dose should remain unchanged, if possible, for the duration of the study.
• Treatment with carbidopa/levodopa, and with a dopamine agonist at the maximal tolerated doses as determined by a movement disorders neurologist.
• Ability and willingness to return for study visits, at the initial programming and after three, six and twelve months of DBS.
• Age \> 18
• Has a history of and/or displays freezing of gait

You may not qualify if:

• Subjects with significant cognitive impairment and/or dementia as determined bya standardized neuropsychological battery.
• Subjects with clinically active depression, defined according to the Diagnostic and Statistical manual of Mental Disorders, Fourth Edition (DSM-IV) criteria and as scored on a validated depression assessment scale.
• Subjects with very advanced Parkinson's disease, Hoehn and Yahr stage 5 on medication (non-ambulatory).
• Age \> 80.
• Subjects with an implanted electronic device such as a neurostimulator, cardiac pacemaker/defibrillator or medication pump.
• Subjects, who are pregnant, are capable of becoming pregnant, or who are breast feeding.
• Patients with cortical atrophy out of proportion to age or focal brain lesions that could indicate a non-idiopathic movement disorder as determined by MRI
• Subjects having a major comorbidity increasing the risk of surgery (prior stroke,severe hypertension, severe diabetes, or need for chronic anti-coagulation other than aspirin).
• Subjects having any prior intracranial surgery.
• Subjects with a history of seizures.
• Subjects, who are immunocompromised.
• Subjects with an active infection.
• Subjects, who require diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) to treat a chronic condition.
• Subjects, who have an inability to comply with study follow-up visits or study protocol.
• Subjects, who are unable to understand or sign the informed consent.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Movement Disorders

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Bronte-Stewart Lab
• Organization: Stanford School of Medicine

hbsmovlab@gmail.com

6507236709

Study Officials

• Helen Bronte-Stewart, MS, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: John E. Cahill Family Profressor, Professor of Neurology and, by courtesy, Neurosurgery at the Stanford University Medical Center

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 8, 2017
• Study Start: May 15, 2017
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: November 21, 2019
• Results First Posted: November 4, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)