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

NCT ID: NCT04677751

Last Updated: 2024-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2025-12-01

Brief Summary

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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

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Conditions

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Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental group

Group Type EXPERIMENTAL

Acupuncture intervention

Intervention Type DEVICE

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

Interventions

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Acupuncture intervention

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Olga Rodziyevska

Physician Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olga Rodziyevska, MS,PA-C

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Olga Rodziyevska, MS,PA-C

Role: CONTACT

(713) 500-5482

Ardonia N Tousant

Role: CONTACT

(713) 500-5482

Facility Contacts

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Olga Rodziyevska, MS,PA-C

Role: primary

(713) 500-5482

Ardonia N Tousant

Role: backup

(713) 500-5482

Other Identifiers

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HSC-MS-20-0743

Identifier Type: -

Identifier Source: org_study_id

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