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

The University of Texas System (UT)

Status: Enrolling

Conditions: Epilepsy

Treatments: Device: Acupuncture intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04677751

HSC-MS-20-0743

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: All

Ages: 15 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Experimental group

Experimental group

Treatment:

Device: Acupuncture intervention