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Clinical Trials/NCT04677751
NCT04677751RecruitingNot Applicable

Clinical and Electrographic Changes in RNS System Patients with Acupuncture Treatment

The University of Texas Health Science Center, Houston2 sites in 1 country10 target enrollmentStarted: April 1, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
10
Locations
2
Primary Endpoint
Percent change in number of disabling clinical seizures
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
15 Years to 60 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Percent change in number of disabling clinical seizures

Time Frame: Baseline,12 weeks post treatment

This will be measured by self reporting journals

Changes in seizure severity

Time Frame: Baseline,12 weeks post treatment

This will be measured by self reporting journals

Secondary Outcomes

  • Average number of detections of seizures per-day (as stored by the RNS System)(1 month after last treatment)
  • Change in cognition and mood as assessed by the Quality Of Life In Epilepsy (QOLIE-10) questionnaire(Baseline,12 weeks post treatment)
  • Change in cognition and mood as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) scale(Baseline,12 weeks post treatment)
  • Change in cognition and mood as assessed by the Patient Health Questionnaire (PHQ-9)(Baseline,12 weeks post treatment)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Olga Rodziyevska

Physician Assistant

The University of Texas Health Science Center, Houston

Study Sites (2)

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