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?

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

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.

Is acupuncture generally safe for humans?

Acupuncture is generally considered safe when performed by well-trained practitioners, but minor side effects like dizziness or local reactions can occur. Serious adverse events are rare, but they can happen, so it's important to ensure the practitioner is properly trained. ^{1 2 3 4 5}

How does acupuncture differ from other treatments for epilepsy?

Acupuncture for epilepsy is unique because it involves stimulating specific points on the body to potentially regulate the nervous system and reduce seizures, unlike conventional treatments that typically involve medication. It can be used alongside medication to enhance effects, and it focuses on balancing the body's energy flow, which is a different approach compared to standard drug therapies. ^{6 7 8 9 10}

What data supports the effectiveness of acupuncture treatment for epilepsy?

While acupuncture has shown promise in reducing symptoms like anxiety and depression in psychiatric care, a study on its use for intractable epilepsy found no significant improvement in patients' quality of life compared to a placebo treatment. ^{11 12 13 14 15}

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

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Ear Acupuncture in Psychiatric Care From the Health Care Professionals' Perspective: A Phenomenographic Analysis. [2022]

2. China pubmed.ncbi.nlm.nih.gov

[Professor TIAN Cong-huo's experience on clinical acupuncture]. [2008]

3. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

[A conceptual framework of the effectiveness of acupuncture]. [2009]

4. China 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]. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Acupuncture in intractable epilepsy: lack of effect on health-related quality of life. [2014]

6. United States pubmed.ncbi.nlm.nih.gov

The Reporting Quality of Acupuncture-Related Infections in Korean Literature: A Systematic Review of Case Studies. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Safety of Acupuncture: Overview of Systematic Reviews. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Acupuncture-related adverse events: systematic review and meta-analyses of prospective clinical studies. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Safety of acupuncture by Korean Medicine Doctors: a prospective, practice-based survey of 37,490 consultations. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Adverse Events Related to Acupuncture: Development and Testing of a Rating Scale. [2016]

11. China pubmed.ncbi.nlm.nih.gov

[Professor LAI Xinsheng's experience of acupuncture combined with medication for epilepsy]. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Acupuncture for epilepsy. [2023]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Acupuncture as an Adjunctive Treatment for Post-stroke Epilepsy: Protocol for a Randomized Controlled Trial. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Electroacupuncture-induced attenuation of experimental epilepsy: a comparative evaluation of acupoints and stimulation parameters. [2021]

15. England pubmed.ncbi.nlm.nih.gov

Activation of amygdala opioid receptors by electroacupuncture of Feng-Chi (GB20) acupoints exacerbates focal epilepsy. [2021]