Acupuncture for Epilepsy

Overseen By Ardonia N Tousant

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Bleeding disorder, Pacemaker, Pregnant

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether acupuncture can help people with epilepsy improve mood and thinking skills, and reduce seizure frequency and severity. It also examines how acupuncture might affect brain activity patterns in patients using the RNS System, a device that monitors brain signals. Suitable candidates for this trial include individuals with epilepsy who already have the RNS System implanted, can maintain their current medications, and can attend acupuncture sessions for 12 weeks. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance epilepsy treatment options.

Do I need to stop my current medications for the trial?

No, you do not need to stop your current medications. The trial requires that you stay on stable medications for 12 weeks.

What prior data suggests that acupuncture is safe for epilepsy?

Research has shown that acupuncture is generally safe and well-tolerated for treating epilepsy. One study found that acupuncture combined with traditional Chinese medicine is safe for children with epilepsy. Another study indicated that combining acupuncture with Western medicine might help manage epilepsy and result in fewer side effects than using Western medicine alone.

Patients who use acupuncture often experience fewer unwanted symptoms or reactions. Although acupuncture is not yet a common treatment for epilepsy, these studies suggest it is a safe option with minimal risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for epilepsy, which often rely on medications like antiepileptic drugs to stabilize electrical activity in the brain, acupuncture offers a non-drug approach. Researchers are excited about acupuncture because it may help reduce seizure frequency by promoting relaxation and improving blood flow, potentially leading to fewer side effects compared to medications. This ancient technique targets specific points on the body, which could offer a new, holistic way to manage epilepsy symptoms without the need for pharmaceuticals.

What evidence suggests that acupuncture might be an effective treatment for epilepsy?

Studies have shown that acupuncture can enhance the overall treatment of epilepsy. It reduces the frequency and severity of seizures when combined with traditional epilepsy treatments. In this trial, participants will receive acupuncture interventions, including electroacupuncture. Research indicates that electroacupuncture can enhance the effectiveness of anti-seizure medications by increasing their levels in the body. Although some studies suggest these benefits, strong evidence supporting acupuncture alone for epilepsy remains limited. However, these early findings offer hope that acupuncture could be a valuable addition to epilepsy care. ^{1 2 4 6 7}

Who Is on the Research Team?

Olga Rodziyevska, MS,PA-C

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Patient is able remain on stable medications 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 has a bleeding disorder, pacemaker, or pregnant

Patient and /or caregiver is unable to sign informed consent to study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive acupuncture treatment to evaluate its effects on mood, cognition, and seizure activity

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acupuncture intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: Experimental group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

A review of 23 observational studies on acupuncture-related adverse events revealed that many did not provide sufficient information to determine the cause of complications, highlighting a gap in reporting quality.

The study emphasizes the need for better involvement of acupuncture experts in reporting adverse events to improve the understanding and safety of acupuncture practices, particularly regarding infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Reporting Quality of Acupuncture-Related Infections in Korean Literature: A Systematic Review of Case Studies. Kim, TH., Kang, JW., Park, WS.[2022]

In a survey of 37,490 acupuncture treatments conducted by 222 Korean Medicine Doctors, adverse events (AEs) were reported at a frequency of 1,205 per 10,000 treatments, with common AEs including bleeding, needle site pain, and bruising.

Most reported AEs were mild and transient, with only two life-threatening cases that resolved without lasting effects, suggesting that acupuncture performed by qualified practitioners is generally safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of acupuncture by Korean Medicine Doctors: a prospective, practice-based survey of 37,490 consultations. Won, J., Lee, JH., Bang, H., et al.[2022]

Acupuncture can lead to adverse events (AEs), including organ or tissue injuries, infections, local reactions, and other complications, with serious AEs being rare but potentially life-threatening, as highlighted by a review of 17 systematic reviews.

The overall methodological quality of the reviews on acupuncture AEs was mediocre, indicating a need for improved research standards and emphasizing the importance of patient safety and acupuncturist training in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Acupuncture: Overview of Systematic Reviews. Chan, MWC., Wu, XY., Wu, JCY., et al.[2022]

Acupuncture has a relatively low risk of adverse events (AEs), with at least one AE occurring in about 9.31% of patients undergoing treatment, and serious adverse events (SAEs) being very rare at approximately 1.01 per 10,000 patients.

The most common minor AEs are mild reactions such as bleeding or pain at the needle site, which are often considered intended effects of acupuncture, highlighting the need for standardized assessment tools to differentiate between adverse reactions and therapeutic responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture-related adverse events: systematic review and meta-analyses of prospective clinical studies. Bäumler, P., Zhang, W., Stübinger, T., et al.[2021]

In a study of 30 children with sleeping disorders due to encephalopathy, the combined therapy of acupuncture at head points and seed-pressure at ear points showed significantly better improvements in sleep resistance and sleep dyspnea compared to simple acupuncture.

While the combined therapy was more effective for certain sleep issues, simple acupuncture was found to be more satisfactory for reducing sleep anxiety and daytime somnolence, indicating that both methods have unique benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical observation of sleeping disorder in children with encephalopathy treated with acupuncture at head points and seed-pressure at ear points]. Lai, S., Wu, Q., Chen, L., et al.[2015]

In a study involving 34 patients with drug-resistant epilepsy, neither traditional acupuncture nor sham acupuncture showed any significant improvement in health-related quality of life after 8 weeks, as measured by the QOLIE-89 questionnaire.

The results indicate that acupuncture, whether real or sham, does not provide a measurable benefit for quality of life in patients suffering from intractable epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture in intractable epilepsy: lack of effect on health-related quality of life. Stavem, K., Kloster, R., Røssberg, E., et al.[2014]

Ear acupuncture is perceived by healthcare professionals as an effective and safe therapeutic tool for managing psychiatric symptoms and addiction, enhancing patient care alongside traditional methods.

The practice of ear acupuncture not only helps patients gain control over their symptoms but also fosters trust and communication between professionals and patients, promoting a person-centered approach to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ear Acupuncture in Psychiatric Care From the Health Care Professionals' Perspective: A Phenomenographic Analysis. Landgren, K., Strand, AS., Ekelin, M., et al.[2022]

The study developed and tested the AcupAE, a 20-item scale for reporting acupuncture-related adverse events (AEs), which was shown to be more effective than open-ended questioning in detecting AEs across different acupuncture treatments in a sample of 150 adults.

The incidence of AEs was significantly higher when assessed with the AcupAE, with 42.4% for acupuncture and 42.2% for minimal acupuncture, compared to only 16.7% for placebo, highlighting the importance of using standardized instruments for accurate AE reporting in acupuncture research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Related to Acupuncture: Development and Testing of a Rating Scale. Chung, KF., Yeung, WF., Yu, YM., et al.[2016]

Acupuncture, which includes various techniques like needling and moxibustion, is recognized as the most credible complementary medical system among healthcare professionals.

The article aims to provide a conceptual framework for understanding acupuncture's effectiveness based on extensive scientific evidence, helping medical personnel better appreciate its potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A conceptual framework of the effectiveness of acupuncture]. Yeh, CC., Wang, CH., Maa, SH.[2009]

Electroacupuncture (EA) significantly reduced epileptic seizures in a rat model, with low-frequency EA showing the best results at specific acupoints (Fenglong and Yongquan), indicating that both the stimulation parameters and acupoint selection are crucial for efficacy.

High-frequency EA was generally more effective than low-frequency EA across most acupoints, suggesting that higher stimulation rates may enhance the therapeutic effects on epilepsy, although the effects of EA were delayed, appearing 1-1.5 hours after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroacupuncture-induced attenuation of experimental epilepsy: a comparative evaluation of acupoints and stimulation parameters. Kang, X., Shen, X., Xia, Y.[2021]

Professor LAI Xinsheng emphasizes the importance of understanding the causes and mechanisms of epilepsy, identifying factors like wind, phlegm, stasis, and deficiency as key contributors to the condition.

The combination of acupuncture, particularly the 'tong-yuan' technique, with medication is proposed to effectively regulate the body's energy and improve treatment outcomes for epilepsy, with careful consideration needed for the use of electroacupuncture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Professor LAI Xinsheng's experience of acupuncture combined with medication for epilepsy]. Fang, Y., Wu, P., Wang, Y., et al.[2018]

This multicentre randomized controlled trial will involve 120 patients with post-stroke epilepsy, comparing the effects of acupuncture combined with routine treatment against sham acupuncture over an 8-week period.

The primary goal is to determine the proportion of patients who become seizure-free, while also assessing the safety of acupuncture by monitoring any adverse events during the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture as an Adjunctive Treatment for Post-stroke Epilepsy: Protocol for a Randomized Controlled Trial. Zhang, Y., Zhao, M., Zhang, B., et al.[2021]

High-frequency electroacupuncture (EA) stimulation at the Feng-Chi (GB20) acupoints did not suppress epileptic activity in a rat model of focal epilepsy; instead, it increased the duration of epileptiform EEGs.

The exacerbation of epilepsy due to EA was linked to the activation of opioid receptors in the central nucleus of the amygdala, as blocking these receptors with antagonists reversed the increased seizure activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Activation of amygdala opioid receptors by electroacupuncture of Feng-Chi (GB20) acupoints exacerbates focal epilepsy. Yi, PL., Lu, CY., Cheng, CH., et al.[2021]

A systematic review of 17 randomized controlled trials involving 1538 participants found that acupuncture does not significantly reduce seizure frequency compared to standard treatments like antiepileptic drugs, indicating limited efficacy for epilepsy management.

While acupuncture may improve quality of life for some patients, the overall evidence is weak and the studies reviewed had high risks of bias, suggesting that acupuncture should not be recommended as a primary treatment for epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for epilepsy. Cheuk, DK., Wong, V.[2023]

Professor TIAN's acupuncture techniques, tailored to individual patient syndromes, have shown effectiveness in treating various difficult conditions, such as using para-acupuncture for migraines and triple puncture at Dazhui for recurrent depression.

Specific acupuncture points, like Shuigou and Baihui, have been utilized with electroacupuncture to address schizophrenia, highlighting the targeted approach in acupuncture treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Professor TIAN Cong-huo's experience on clinical acupuncture]. Song, SY., Wang, Y.[2008]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11216577/

Efficacy of acupuncture combined with traditional Chinese ... In recent years, acupuncture has shown positive therapeutic effects in improving overall effectiveness of epilepsy treatment, reducing the ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S209738292500054X

Electroacupuncture promotes the efficacy of anti-seizure ... The results of the present study indicated that EA could improve the therapeutic efficacy of ASDs by enhancing the concentration of drugs in the ...

3. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2023.1203231/full

Effectiveness of acupuncture as auxiliary combined with ... The results of the analysis suggested that acupuncture combined with Western medicine is probably helpful in patients with epilepsy, but strong supportive data ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10397512/

a systematic review and meta-analysis - PMC - PubMed Central The results of the analysis suggested that acupuncture combined with Western medicine is probably helpful in patients with epilepsy, but strong supportive data ...

5. journals.plos.org journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0297410&type=printable

Efficacy of acupuncture combined with traditional Chinese ... In recent years, acupuncture has shown positive therapeutic effects in improving overall effectiveness of epi- lepsy treatment, reducing the ...

6. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0303201

A meta-analysis of randomized controlled trials | PLOS One The meta-analysis suggested that combined use of herbal medicine and acupuncture is a promising and safe clinical approach for pediatric epilepsy treatment.

7. journals.lww.com journals.lww.com/md-journal/fulltext/2025/09120/efficacy_and_safety_in_treating_refractory.59.aspx

Efficacy and safety in treating refractory epilepsy with a. ... Compared with Western medicine, TCM treatment is associated with fewer adverse effects and higher patient compliance. ... Some studies have shown ...