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

Epilepsy Clinical Trial

Official title:

Clinical and Electrographic Changes in RNS System Patients With Acupuncture Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04677751
• Other study ID #: HSC-MS-20-0743
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: February 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Olga Rodziyevska, MS,PA-C
• Phone: (713) 500-5482
• Email: Olga.Rodziyevska[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in number of disabling clinical seizures	This will be measured by self reporting journals	Baseline,12 weeks post treatment
Primary	Changes in seizure severity	This will be measured by self reporting journals	Baseline,12 weeks post treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	Average number of detections of seizures per-day (as stored by the RNS System)		Baseline
Secondary	Average number of detections of seizures per-day (as stored by the RNS System)		end of 1 month
Secondary	Average number of detections of seizures per-day (as stored by the RNS System)		end of 2 months
Secondary	Average number of detections of seizures per-day (as stored by the RNS System)		end of 3 months
Secondary	Average number of detections of seizures per-day (as stored by the RNS System)		1 month after last treatment