N/A Completed N=12 Randomized Triple-blind Treatment

Low Frequency Subthalamic Nucleus Deep Brain Stimulation to Improve Verbal Fluency

Source: ClinicalTrials.gov NCT04383665 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2021

Primary outcomePrimary: Delis-Kaplan Executive Function System Verbal Fluency — 12.75; 13.25; 13.58; 13.83 Words per minute

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Delis-Kaplan Executive Function System Verbal Fluency	12.75; 13.25; 13.58; 13.83; 11.33; 11.83	—
PRIMARY Delis-Kaplan Executive Function System Color Word Interference Task	33.83; 35.00; 34.33; 24.58; 24.75; 24.17	—
PRIMARY Random Number Generation	0.35; 0.35; 0.37; -3.10; -3.21; -2.90	—

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04383665). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.