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

NCT04677751 | Recruiting FDA Device

• 1 other identifier: HSC-MS-20-0743
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Epilepsy

Keywords

acupuncture; RNS; seizure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• 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 Patient Health Questionnaire (PHQ-9)

  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

• 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

Study Arms (1)

Experimental group

EXPERIMENTAL

Device: Acupuncture intervention

Interventions

Acupuncture intervention DEVICE

Participants will undergo 12 weeks of acupuncture therapy. There will be one 40 minute-1 hour. session per week.

Experimental group

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Olga Rodziyevska, MS,PA-C

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga Rodziyevska, MS,PA-C

CONTACT

(713) 500-5482; Olga.Rodziyevska@uth.tmc.edu

Ardonia N Tousant

CONTACT

(713) 500-5482; Ardonia.N.Tousant@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician Assistant

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 21, 2020
• Study Start: April 1, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)