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

Not Applicable

Recruiting

• Conditions: Epilepsy
• Interventions: Device: Acupuncture intervention

• Registration Number: NCT04677751
• Lead Sponsor: The University of Texas Health Science Center, Houston

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-15
• Study First Posted: 2020-12-21
• Study Start: 2021-04-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-10-01
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Acupuncture intervention	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Average number of detections of seizures per-day (as stored by the RNS System)	1 month after last treatment
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.
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)
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).

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States