Recruiting

Acupuncture

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT04677751

Conditions

Epilepsy

Eligibility Criteria

Sex: All

Age: 15 - 60

Healthy Volunteers: Not accepted

Interventions

Acupuncture intervention

Study Details

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

Conditions

Epilepsy

Study ID

NCT04677751

Start date

Apr 1, 2021

Status verified date

Jul, 2024

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 60

Healthy Volunteers: Not accepted

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

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Experimental group

Interventions

Acupuncture intervention

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

Primary outcome measure

  • Percent change in number of disabling clinical seizures [ Time Frame: Baseline,12 weeks post treatment ]
  • Changes in seizure severity [ Time Frame: Baseline,12 weeks post treatment ]

Central Contacts and Locations

Central contacts

Olga Rodziyevska, MS,PA-C

(713) 500-5482Olga.Rodziyevska@uth.tmc.edu

Ardonia N Tousant

(713) 500-5482Ardonia.N.Tousant@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Olga Rodziyevska, MS,PA-C

(713) 500-5482Olga.Rodziyevska@uth.tmc.edu

Ardonia N Tousant

(713) 500-5482Ardonia.N.Tousant@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Oct 1, 2024

Last verified

Jul, 2024

Keywords

  • acupuncture
  • RNS
  • seizure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2024-10-01.