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Low Frequency Subthalamic Nucleus Deep Brain Stimulation to Improve Verbal Fluency

University of Southern California logo

University of Southern California

Status

Completed

Conditions

Parkinson Disease

Treatments

Device: STN DBS 130Hz
Device: STN DBS 10Hz
Device: STN DBS off

Study type

Interventional

Funder types

Other

Identifiers

NCT04383665
HS-19-00518

Details and patient eligibility

About

Rationale: Parkinson's disease patients with deep brain stimulation electrodes represent a unique opportunity to study the influence of basal ganglia on neurocognitive function.

Intervention: Patients' deep brain stimulators will be turned off or on and the frequency will be changed to either theta or gamma.

Objectives: To identify differences in higher cognitive functions with stimulation "on" and "off" and theta versus gamma frequency stimulation.

Study population: 12 patients who had previously undergone bilateral STN deep brain stimulation implantation.

Study methodology: Patients will undergo four sessions of neuropsychological testing (RNGT, verbal fluency, D-KEFS CWIT) at baseline, no stimulation, theta stimulation and gamma stimulation, in random order over one day.

Study outcomes: Test results of RNGT, verbal fluency, D-KEFS CWIT. Follow-up: none

Statistics: Test results will be analyzed using within-subjects statistical tests.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Male or female patients who had previously undergone bilateral STN deep brain stimulation implantation
  2. Age >18 years old
  3. Stable medication regimen for at least 3 months.
  4. Patient informed and able to give written consent
  5. Able to comply with all testing, follow-ups and study appointments and protocols

Exclusion criteria

  1. History of epilepsy or seizure
  2. History of major substance abuse
  3. Patients with baseline settings at less than 1.5 V will be excluded from the study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

12 participants in 3 patient groups

STN DBS off
Sham Comparator group
Treatment:
Device: STN DBS off
STN DBS 10Hz
Experimental group
Treatment:
Device: STN DBS 10Hz
STN DBS 130Hz
Active Comparator group
Treatment:
Device: STN DBS 130Hz

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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