Status:

RECRUITING

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

Lead Sponsor:

The University of Texas Health Science Center, Houston

Conditions:

Epilepsy

Eligibility:

All Genders

15-60 years

Phase:

NA

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 Acupunc...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

April 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT04677751

Start Date

April 1 2021

End Date

December 1 2025

Last Update

October 1 2024

Active Locations (1)

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The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030