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

NCT ID: NCT02304848

Last Updated: 2019-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2017-11-28

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DBS (Deep Brain Stimulation)

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

Group Type: EXPERIMENTAL

DBS (Deep Brain Stimulation)

Intervention Type: OTHER

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

Interventions

DBS (Deep Brain Stimulation)

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Helen M. Bronte-Stewart

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helen Bronte-Stewart, MD, MSE, FAAN

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University Medical Center

Stanford, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32348346 (View on PubMed)

Other Identifiers

60130

Identifier Type: -

Identifier Source: org_study_id