Clinical and Electrographic Changes in Responsive Neurostimulation System (RNS) Patients with Acupuncture Treatment

Clinical and Electrographic Changes in RNS System Patients with Acupuncture Treatment

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

Study Overview

• Status: Recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Device: Acupuncture intervention

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olga Rodziyevska, MS,PA-C; Phone Number: (713) 500-5482; Email: Olga.Rodziyevska@uth.tmc.edu
• Study Contact Backup: Name: Ardonia N Tousant; Phone Number: (713) 500-5482; Email: Ardonia.N.Tousant@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Olga Rodziyevska, MS,PA-C; Phone Number: (713) 500-5482; Email: Olga.Rodziyevska@uth.tmc.edu
      • Contact: Ardonia N Tousant; Phone Number: (713) 500-5482; Email: Ardonia.N.Tousant@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group	Device: Acupuncture intervention; Participants will undergo 12 weeks of acupuncture therapy. There will be one 40 minute-1 hour. session per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in number of disabling clinical seizures	This will be measured by self reporting journals	Baseline,12 weeks post treatment
Changes in seizure severity	This will be measured by self reporting journals	Baseline,12 weeks post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cognition and mood as assessed by the Quality Of Life In Epilepsy (QOLIE-10) questionnaire	This is a 10 item questionnaire. Score ranges from 1-6,a higher number indicating a worse outcome.	Baseline,12 weeks post treatment
Change in cognition and mood as assessed by the Patient Health Questionnaire (PHQ-9)	PHQ-9 score can range from 0 to 27,each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day).	Baseline,12 weeks post treatment
Change in cognition and mood as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) scale	This is a 7 item questionnaire. Each question is scored form 0(not at alll) to 3(nearly every day)	Baseline,12 weeks post treatment
Average number of detections of seizures per-day (as stored by the RNS System)		Baseline
Average number of detections of seizures per-day (as stored by the RNS System)		end of 1 month
Average number of detections of seizures per-day (as stored by the RNS System)		end of 2 months
Average number of detections of seizures per-day (as stored by the RNS System)		end of 3 months
Average number of detections of seizures per-day (as stored by the RNS System)		1 month after last treatment

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Olga Rodziyevska, MS,PA-C, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 27, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: acupuncture; seizure; RNS
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: HSC-MS-20-0743

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No