EpilepsyNCT04677751
Clinical and Electrographic Changes in Responsive Neurostimulation System (RNS) Patients With Acupuncture Treatment
A study testing Acupuncture intervention in people with Epilepsy, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Acupuncture intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Patient and /or caregiver is unable to sign informed consent to study
- Patient has a bleeding disorder, pacemaker, or pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Olga Rodziyevska, MS,PA-C, (713) 500-5482, Olga.Rodziyevska@uth.tmc.edu
Ardonia N Tousant, (713) 500-5482, Ardonia.N.Tousant@uth.tmc.edu
About this study
Official title: Clinical and Electrographic Changes in RNS System Patients With Acupuncture Treatment
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
- Being tested
- Acupuncture intervention
- Keywords
- acupuncture, RNS, seizure
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture interventionDevice
Participants will undergo 12 weeks of acupuncture therapy. There will be one 40 minute-1 hour. session per week.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Device: Acupuncture intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in number of disabling clinical seizures
This will be measured by self reporting journals
Measured: Baseline,12 weeks post treatment
Changes in seizure severity
This will be measured by self reporting journals
Measured: Baseline,12 weeks post treatment
Secondary outcomes (8)
Change in cognition and mood as assessed by the Quality Of Life In Epilepsy (QOLIE-10) questionnaire
This is a 10 item questionnaire. Score ranges from 1-6,a higher number indicating a worse outcome.
Measured: Baseline,12 weeks post treatment
Change in cognition and mood as assessed by the Patient Health Questionnaire (PHQ-9)
PHQ-9 score can range from 0 to 27,each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day).
Measured: Baseline,12 weeks post treatment
Change in cognition and mood as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) scale
This is a 7 item questionnaire. Each question is scored form 0(not at alll) to 3(nearly every day)
Measured: Baseline,12 weeks post treatment
Average number of detections of seizures per-day (as stored by the RNS System)
Measured: Baseline
Average number of detections of seizures per-day (as stored by the RNS System)
Measured: end of 1 month
Average number of detections of seizures per-day (as stored by the RNS System)
Measured: end of 2 months
Average number of detections of seizures per-day (as stored by the RNS System)
Measured: end of 3 months
Average number of detections of seizures per-day (as stored by the RNS System)
Measured: 1 month after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Apr 2021
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Rodziyevska, The University of Texas Health Science Center, Houston
- Investigators
- Olga Rodziyevska, MS,PA-C, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677751
- Sponsor's protocol ID
- HSC-MS-20-0743
- Status last verified
- Oct 2026
- First submitted
- 15 Dec 2020
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Electrographic Changes in RNS System Patients With Acupuncture Treatment
- ClinicalTrials.gov ID
- NCT04677751
- Acronym / sponsor ID
- HSC-MS-20-0743
- Conditions
- Epilepsy
- Keywords
- acupuncture, RNS, seizure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Acupuncture intervention |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Patient and /or caregiver is unable to sign informed consent to study
- Patient has a bleeding disorder, pacemaker, or pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture interventionParticipants will undergo 12 weeks of acupuncture therapy. There will be one 40 minute-1 hour. session per week. | Device | Experimental group |
Primary outcome
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
8 secondary outcomes
Change in cognition and mood as assessed by the Quality Of Life In Epilepsy (QOLIE-10) questionnaire
Time frame: Baseline,12 weeks post treatment
Change in cognition and mood as assessed by the Patient Health Questionnaire (PHQ-9)
Time frame: Baseline,12 weeks post treatment
Change in cognition and mood as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) scale
Time frame: Baseline,12 weeks post treatment
Average number of detections of seizures per-day (as stored by the RNS System)
Time frame: Baseline
Average number of detections of seizures per-day (as stored by the RNS System)
Time frame: end of 1 month
Average number of detections of seizures per-day (as stored by the RNS System)
Time frame: end of 2 months
Average number of detections of seizures per-day (as stored by the RNS System)
Time frame: end of 3 months
Average number of detections of seizures per-day (as stored by the RNS System)
Time frame: 1 month after last treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olga Rodziyevska, MS,PA-C principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture intervention in people with Epilepsy, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olga Rodziyevska, MS,PA-C ((713) 500-5482, Olga.Rodziyevska@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in number of disabling clinical seizures (time frame: Baseline,12 weeks post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.