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

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Recruiting
CT.gov ID
NCT04677751
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
20
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: Acupuncture intervention
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Clinical and Electrographic Changes in RNS System Patients With Acupuncture Treatment
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Percent change in number of disabling clinical seizures [Baseline,12 weeks post treatment]

    This will be measured by self reporting journals

  2. Changes in seizure severity [Baseline,12 weeks post treatment]

    This will be measured by self reporting journals

Secondary Outcome Measures

  1. Change in cognition and mood as assessed by the Quality Of Life In Epilepsy (QOLIE-10) questionnaire [Baseline,12 weeks post treatment]

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

  2. Change in cognition and mood as assessed by the Patient Health Questionnaire (PHQ-9) [Baseline,12 weeks post treatment]

    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).

  3. Change in cognition and mood as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) scale [Baseline,12 weeks post treatment]

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

  4. Average number of detections of seizures per-day (as stored by the RNS System) [Baseline]

  5. Average number of detections of seizures per-day (as stored by the RNS System) [end of 1 month]

  6. Average number of detections of seizures per-day (as stored by the RNS System) [end of 2 months]

  7. Average number of detections of seizures per-day (as stored by the RNS System) [end of 3 months]

  8. Average number of detections of seizures per-day (as stored by the RNS System) [1 month after last treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Texas Health Science Center at Houston Houston Texas United States 77030

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Olga Rodziyevska, Physician Assistant, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT04677751
Other Study ID Numbers:
  • HSC-MS-20-0743
First Posted:
Dec 21, 2020
Last Update Posted:
Oct 21, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Olga Rodziyevska, Physician Assistant, The University of Texas Health Science Center, Houston
acupuncture
RNS
seizure
Additional relevant MeSH terms:
Epilepsy

Study Results

No Results Posted as of Oct 21, 2021