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

Primary Purpose

Epilepsy

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Acupuncture intervention

About this trial

This is an interventional supportive care trial for Epilepsy focused on measuring acupuncture, RNS, seizure

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental group

Arm Description

Outcomes

Primary Outcome Measures

Percent change in number of disabling clinical seizures

This will be measured by self reporting journals

Changes in seizure severity

This will be measured by self reporting journals

Secondary Outcome Measures

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.

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).

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)

Average number of detections of seizures per-day (as stored by the RNS System)

Full Information

NCT ID

NCT04677751

First Posted

December 15, 2020

Last Updated

February 14, 2023

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT04677751

Brief Title

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

Official Title

Clinical and Electrographic Changes in RNS System Patients With Acupuncture Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2021 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy

Keywords

acupuncture, RNS, seizure

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Acupuncture intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Percent change in number of disabling clinical seizures

Description

This will be measured by self reporting journals

Time Frame

Baseline,12 weeks post treatment

Title

Changes in seizure severity

Description

This will be measured by self reporting journals

Time Frame

Baseline,12 weeks post treatment

Secondary Outcome Measure Information:

Title

Change in cognition and mood as assessed by the Quality Of Life In Epilepsy (QOLIE-10) questionnaire

Description

This is a 10 item questionnaire. Score ranges from 1-6,a higher number indicating a worse outcome.

Time Frame

Baseline,12 weeks post treatment

Title

Change in cognition and mood as assessed by the Patient Health Questionnaire (PHQ-9)

Description

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).

Time Frame

Baseline,12 weeks post treatment

Title

Change in cognition and mood as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) scale

Description

This is a 7 item questionnaire. Each question is scored form 0(not at alll) to 3(nearly every day)

Time Frame

Baseline,12 weeks post treatment

Title

Average number of detections of seizures per-day (as stored by the RNS System)

Time Frame

Baseline

Title

Average number of detections of seizures per-day (as stored by the RNS System)

Time Frame

end of 1 month

Title

Average number of detections of seizures per-day (as stored by the RNS System)

Time Frame

end of 2 months

Title

Average number of detections of seizures per-day (as stored by the RNS System)

Time Frame

end of 3 months

Title

Average number of detections of seizures per-day (as stored by the RNS System)

Time Frame

1 month after last treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Olga Rodziyevska, MS,PA-C

Phone

(713) 500-5482

Olga.Rodziyevska@uth.tmc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Ardonia N Tousant

Phone

(713) 500-5482

Ardonia.N.Tousant@uth.tmc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Olga Rodziyevska, MS,PA-C

Organizational Affiliation

The University of Texas Health Science Center, Houston

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Texas Health Science Center at Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Olga Rodziyevska, MS,PA-C

Phone

713-500-5482

Olga.Rodziyevska@uth.tmc.edu

First Name & Middle Initial & Last Name & Degree

Ardonia N Tousant

Phone

(713) 500-5482

Ardonia.N.Tousant@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD

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

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