Clinical and Electrographic Changes in RNS System Patients with Acupuncture Treatment

The University of Texas Health Science Center, Houston1 site in 1 country10 target enrollmentApril 1, 2021

ConditionsEpilepsy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Epilepsy
Sponsor: The University of Texas Health Science Center, Houston
Enrollment: 10
Locations: 1
Primary Endpoint: Percent change in number of disabling clinical seizures
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine effects of Acupuncture on a Patient's mood and cognition,evaluate changes in clinically-reported seizure frequency and severity and analyze effects of Acupuncture on electrographic epileptiform activity stored by the RNS System

Registry

clinicaltrials.gov

Start Date

April 1, 2021

End Date

December 1, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

The University of Texas Health Science Center, Houston

Responsible Party

Principal Investigator

Olga Rodziyevska

Physician Assistant

The University of Texas Health Science Center, Houston

Eligibility Criteria

Inclusion Criteria

•Patient implanted with the RNS system
•Patient can undergo 12 weeks of acupuncture
•Patient is able remain on stable medications for 12 weeks
•Patient is able to remain on stable Detection and Stimulation settings for 12 weeks
•Patient or/and caregiver is able to understand and sign informed consent and HIPAA authorization
•Patient or caregiver able to maintain a seizure diary for duration of study

Exclusion Criteria

•Patient and /or caregiver is unable to sign informed consent to study
•Patient has a bleeding disorder, pacemaker, or pregnant

Outcomes

Primary Outcomes

Percent change in number of disabling clinical seizures

Time Frame: Baseline,12 weeks post treatment

This will be measured by self reporting journals

Changes in seizure severity

Time Frame: Baseline,12 weeks post treatment

This will be measured by self reporting journals

Secondary Outcomes

Average number of detections of seizures per-day (as stored by the RNS System)(1 month after last treatment)
Change in cognition and mood as assessed by the Quality Of Life In Epilepsy (QOLIE-10) questionnaire(Baseline,12 weeks post treatment)
Change in cognition and mood as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) scale(Baseline,12 weeks post treatment)
Change in cognition and mood as assessed by the Patient Health Questionnaire (PHQ-9)(Baseline,12 weeks post treatment)