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Acupuncture for Epilepsy
N/A
Recruiting
Led By Olga Rodziyevska, MS,PA-C
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline,12 weeks post treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the effects of acupuncture on mood, cognition, seizure frequency, and severity in patients with epilepsy.
Who is the study for?
This trial is for epilepsy patients with an RNS system who can keep their medications and device settings stable for 12 weeks. They must be able to understand and sign consent forms, maintain a seizure diary, and undergo acupuncture. It's not for those with bleeding disorders, pacemakers, or pregnant individuals.
What is being tested?
The study tests if acupuncture affects mood, cognition, seizure frequency/severity in epilepsy patients using the RNS System. It also examines changes in brain activity recorded by the RNS device during treatment.
What are the potential side effects?
While specific side effects of acupuncture are not detailed here, common ones include soreness where needles are inserted, minor bleeding or bruising at needle sites, and relaxation or energization.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline,12 weeks post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline,12 weeks post treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in seizure severity
Seizures
Secondary study objectives
Change in cognition and mood as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) scale
Change in cognition and mood as assessed by the Patient Health Questionnaire (PHQ-9)
Change in cognition and mood as assessed by the Quality Of Life In Epilepsy (QOLIE-10) questionnaire
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental groupExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
347,850 Total Patients Enrolled
8 Trials studying Epilepsy
499 Patients Enrolled for Epilepsy
Olga Rodziyevska, MS,PA-CPrincipal InvestigatorThe University of Texas Health Science Center, Houston
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical device called the RNS system implanted in your body.You are able to have acupuncture treatments for 12 weeks.You can keep the same settings for your medical devices for at least 12 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.