RecruitingNot ApplicableNCT04677751

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

Clinical and Electrographic Changes in RNS System Patients with Acupuncture Treatment


Sponsor

The University of Texas Health Science Center, Houston

Enrollment

10 participants

Start Date

Apr 1, 2021

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 15 YearsMax Age: 60 Years

Inclusion Criteria6

  • 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 Criteria2

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

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Interventions

DEVICEAcupuncture intervention

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


Locations(1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

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NCT04677751


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