Clinical trial NCT03180515: Neural and Kinematic Features of Freezing of Gait for Adaptive Neurostimulation
Official title: Neural and Kinematic Features of Freezing of Gait for Adaptive Neurostimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-06-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

1. A diagnosis of idiopathic Parkinson's disease, with bilateral symptoms at Hoehn and Yahr Stage greater than or equal to II.
2. 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.
3. 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.
4. 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.
5. Treatment with carbidopa/levodopa, and with a dopamine agonist at the maximal tolerated doses as determined by a movement disorders neurologist.
6. Ability and willingness to return for study visits, at the initial programming and after three, six and twelve months of DBS.
7. Age \> 18
8. Has a history of and/or displays freezing of gait

Exclusion Criteria:

1. Subjects with significant cognitive impairment and/or dementia as determined bya standardized neuropsychological battery.
2. 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.
3. Subjects with very advanced Parkinson's disease, Hoehn and Yahr stage 5 on medication (non-ambulatory).
4. Age \> 80.
5. Subjects with an implanted electronic device such as a neurostimulator, cardiac pacemaker/defibrillator or medication pump.
6. Subjects, who are pregnant, are capable of becoming pregnant, or who are breast feeding.
7. 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
8. 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).
9. Subjects having any prior intracranial surgery.
10. Subjects with a history of seizures.
11. Subjects, who are immunocompromised.
12. Subjects with an active infection.
13. Subjects, who require diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) to treat a chronic condition.
14. Subjects, who have an inability to comply with study follow-up visits or study protocol.
15. Subjects, who are unable to understand or sign the informed consent.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Related to aDBS
timeFrame: 30 min - 2 hours
Secondary outcomes:
measure: Aim 1: Alpha Power
timeFrame: 30 minutes
measure: Aim 1: Beta Power
timeFrame: 30 minutes
measure: Aim 1: Alpha Sample Entropy
timeFrame: 30 minutes
measure: Aim 1: Beta Sample Entropy
timeFrame: 30 minutes
measure: Aim 2: Asymmetry
timeFrame: 30 minutes
measure: Aim 2: Arrhythmicity
timeFrame: 30 minutes
measure: Aim 2: Stride Time
timeFrame: 30 minutes
measure: Aim 2: Percent Time Freezing
timeFrame: 30 minutes
measure: Percent Time Freezing
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Movement Disorders
state: California
Study officials:
affiliation: Stanford University
name: Helen Bronte-Stewart, MS, MD
role: PRINCIPAL_INVESTIGATOR
References: