Effects of Deep Brain Stimulation (DBS) Frequency on Neural Synchrony

NCT02304848 | Completed

• 1 other identifier: 60130
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effects of low frequency deep brain stimulation on subthalamic nucleus neural synchrony. Low frequency stimulation does not improve the cardinal motor signs of Parkinson's disease, and may be beneficial only for gait and speech. This study will provide insight into what the effects of low frequency stimulation are on neural synchrony.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; DBS; Deep Brain Stimulation; Subthalamic Nucleus

Outcome Measures

Primary Outcomes (1)

• Low frequency stimulation versus no stimulation

  The changes in neuronal oscillations, measured in power (dB/Hz) and frequency (Hz), that are significantly different between periods of low frequency stimulation and periods of no stimulation - during rest - in people with Parkinson's disease off medications.

  3 years

Secondary Outcomes (1)

• Low frequency stimulation versus high frequency stimulation

  3 years

Study Arms (1)

DBS (Deep Brain Stimulation)

EXPERIMENTAL

DBS ( Deep Brain Stimulation) ( both high and low frequency deep brain stimulation will be applied to the subthalamic nucleus)

Other: DBS (Deep Brain Stimulation)

Interventions

DBS (Deep Brain Stimulation) OTHER

Applying low frequency and high frequency deep brain stimulation to subthalamic nucleus.

DBS (Deep Brain Stimulation)

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.
• Age \> 18

You may not qualify if:

• Subjects with significant cognitive impairment and/or dementia as determined by a 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 anticoagulation 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.
• Subjects, who are unable to understand or sign the informed consent

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Related Publications (1)

• O'Day J, Syrkin-Nikolau J, Anidi C, Kidzinski L, Delp S, Bronte-Stewart H. The turning and barrier course reveals gait parameters for detecting freezing of gait and measuring the efficacy of deep brain stimulation. PLoS One. 2020 Apr 29;15(4):e0231984. doi: 10.1371/journal.pone.0231984. eCollection 2020.

  PMID: 32348346 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Helen Bronte-Stewart, MD, MSE, FAAN

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: December 2, 2014
• Study Start: October 1, 2012
• Primary Completion: November 28, 2017
• Study Completion: November 28, 2017
• Last Updated: March 11, 2019

Record last verified: 2019-03

Locations

US (1)