Low Frequency Subthalamic Nucleus Deep Brain Stimulation to Improve Verbal Fluency

Parkinson Disease Clinical Trial

Official title:

Evaluation of Neurocognitive Changes in Parkinson's Disease Patients Following Acute Low Frequency Deep Brain Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04383665
• Other study ID #: HS-19-00518
• Status: Completed
• Phase: N/A
• Start date: January 31, 2020
• Est. completion date: March 3, 2020

Study information

• Verified date: June 2021
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 3, 2020
• Est. primary completion date: March 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• STN DBS 10Hz
Stimulation of existing DBS device at 100Hz, with other parameters at baseline
• STN DBS 130Hz
Stimulation of existing DBS device at 130Hz, with other parameters at baseline
• STN DBS off
Existing DBS device turned off

Locations

Country	Name	City	State
United States	Keck hospital of the University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (3)

Evans FJ. Monitoring attention deployment by random number generation: An index to measure subjective randomness. Bull Psychon Soc 1978;12:35-8.

Spatt J, Goldenberg G. Components of random generation by normal subjects and patients with dysexecutive syndrome. Brain Cogn. 1993 Nov;23(2):231-42. — View Citation

Towse JN, Neil D. Analyzing human random generation behavior: A review of methods used and a computer program for describing performance. Behav Res Methods Instrum Comput 1998;30:583-91.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delis-Kaplan Executive Function System Verbal Fluency	Number of words per category in one minute	5-15 minutes following stimulation frequency setting change.
Primary	Delis-Kaplan Executive Function System Color Word Interference Task	Time to completion of a color-word interference task	5-15 minutes following stimulation frequency setting change.
Primary	Random Number Generation	Listing of 100 numbers at 1 Hz in a random order.; Evan's RNG: a measure of disproportion with which one number follows another in a sequence. Scores range from 0 (equal proportion of sequence pairs) to 1 (maximum disproportion of sequence pairs). A higher score indicates a lower randomness and poorer exective function.; Count score 1: a measure of propensity to count in steps of 1. The length of each sequence with steps of 1 is squared. The total of these is summed. Scores range from 0 (no sequences with steps of 1) to 100000 (all sequences with steps of 1). A higher score indicates lower randomness and poorer exective function.; Count score 2: a measure of propensity to count in steps of 2. The length of each sequence with steps of 2 is squared. The total of these is summed. Scores range from 0 (no sequences with steps of 2) to 100000 (all sequences with steps of 2). A higher score indicates lower randomness and poorer exective function.; Evan's RNG, count score 1 and cou	5-15 minutes following stimulation frequency setting change.

External Links

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