Acupuncture for Epilepsy
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The University of Texas Health Science Center, Houston
Disqualifiers: Bleeding disorder, Pacemaker, Pregnant
No Placebo Group
Approved in 5 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
678910How 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.
1112131415Eligibility Criteria
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
+3 more
Exclusion Criteria
Patient has a bleeding disorder, pacemaker, or pregnant
Patient and /or caregiver is unable to sign informed consent to study
Trial Timeline
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Experimental groupExperimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of Texas Health Science Center at HoustonHouston, TX
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Who Is Running the Clinical Trial?
The University of Texas Health Science Center, HoustonLead Sponsor
References
Ear Acupuncture in Psychiatric Care From the Health Care Professionals' Perspective: A Phenomenographic Analysis. [2022]Ear acupuncture is used as a non-pharmacological complement in psychiatric and addiction care to reduce anxiety, depression and insomnia. The aim of this study was to describe health care professionals' perceptions of giving ear acupuncture in different psychiatric settings. Twenty-four professionals providing ear acupuncture to patients with a variety of psychiatric symptoms and/or addiction were interviewed in focus groups. Data were analyzed with a phenomenographic approach. Ear acupuncture was provided, individually or in groups, to in- and outpatients with a variety of psychiatric symptoms and/or addiction. Three descriptive categories emerged: Another tool in the toolbox, Strengthening the profession and Person-centered care. Participants perceived ear acupuncture to be an effective and safe therapeutic tool, easy to use in concert with other methods and easy to adjust to the patients' needs and requests. They perceived that their professional self-confidence increased when having this non-verbal, person-centered and non-pharmacological tool in their hands as a complement to ordinary care. Professionals perceived that patients trained their social skills while participating in acupuncture, and that the treatment helped patients to influence their subjective psychiatric health through gaining control over symptoms. Acupuncture helped professionals to build a trustful relationship and communicate with their patients, verbally and non-verbally. The finding shows ear acupuncture as a safe treatment and promising in relieving psychiatric and somatic symptoms. Acupuncture facilitates the communication with patient, emphasizing participation and shared decision-making, valuable dimensions of person-centered care. Managers' role and attitude in supporting staff needs to be explored in future research.
[Professor TIAN Cong-huo's experience on clinical acupuncture]. [2008]Professor TIAN's experiences on acupuncture treatment of various difficult diseases with different acupuncture methods based on syndrome differentiation of different patients, for example, para-acupuncture for treatment of migraine, triple puncture at Dazhui (GV 14) for recurrent depression, lifting and thrusting point Shexiaxue for treatment of aphasia, electroacupuncture at Shuigou (GV 26) and Baihui (GV 20) for treatment of schizophrenia, etc. are introduced.
[A conceptual framework of the effectiveness of acupuncture]. [2009]The term, "Acupuncture," is used in its broadest senses to refer to needling, moxibustion, acupressure, laser acupuncture, electric acupuncture, and microsystem acupuncture, such as ear, face, hand and scalp acupuncture. Numerous surveys show that, of all the complementary medical systems, acupuncture enjoys the most credibility in the medical community. This article introduces a conceptual framework of the effectiveness of acupuncture from the perspective of responses to acupuncture shown in extensive, basic scientific evidence. The researchers hope, through this review of literature, to enable medical personnel to gain something of an understanding of acupuncture.
[Clinical observation of sleeping disorder in children with encephalopathy treated with acupuncture at head points and seed-pressure at ear points]. [2015]To compare the difference of clinical efficacy on sleeping disorder in the children with encephalopathy between the combined therapy of acupuncture at head points and seed-pressure at ear points and the simple acupuncture at head points.
Acupuncture in intractable epilepsy: lack of effect on health-related quality of life. [2014]The objective of this study was to assess the effect on health-related quality of life of acupuncture and sham acupuncture as adjunctive treatment in intractable epilepsy. We performed a randomized controlled trail with two parallel treatment arms at The National Center for Epilepsy in Norway, a comprehensive epilepsy center. Thirty-four patients with long-standing drug resistant epilepsy completed the study. The intervention consisted of 20 acupuncture treatments (bilateral needling of three acupoints plus one or two individually chosen points) or sham acupuncture (bilateral needling with smaller needles of three points outside the traditional meridians) over 8 weeks. The main outcome measures were changes in mean health-related quality of life scores for the two groups after 8 weeks, using the 89-item Quality of Life in Epilepsy (QOLIE-89) questionnaire. We found no difference between the acupuncture and sham acupuncture groups in score changes in any dimension of the QOLIE-89 questionnaire, despite testing a large number of dimensions. We also found no change in QOLIE-89 scores between baseline and 8 weeks in either groups. In conclusion, we could not demonstrate a significant effect of traditional acupuncture or sham acupuncture on the health-related quality of life of patients with intractable epilepsy.
The Reporting Quality of Acupuncture-Related Infections in Korean Literature: A Systematic Review of Case Studies. [2022]Objective. Acupuncture is generally accepted as a safe intervention when it is administered in appropriate clinical setting by well-educated and experienced practitioners. In this study, we reviewed observational studies on adverse events (AEs) or complications relevant to acupuncture practice in Korean literature for assessing their reporting quality and suggested recommendations for future ones on acupuncture-related infections. Method. Electronic databases including Medline, Embase, Cochrane library, Korean studies Information Service System, DBpia, National Digital Science Library, and Korean National Assembly Library were searched until May 2015. Combination of keywords including "acupuncture" and "infection" were used for searching databases. Result. A total of 23 studies from 2,739 literature articles were identified from electronic database searching until May 2015. From this review, we found that most case studies did not report enough information for judging causality between acupuncture and the AEs (or complications) as well as appropriateness of the acupuncture practice. In addition, acupuncture experts rarely participated in the reporting of these AEs (or complications). Conclusion. Based on these limitations, we suggest a tentative recommendation for future case studies on acupuncture-related infection. We hope that this recommendation would contribute to the improvement of the reporting quality of acupuncture-related AEs (or complications) in the future.
Safety of Acupuncture: Overview of Systematic Reviews. [2022]Acupuncture is increasingly used worldwide. It is becoming more accepted by both patients and healthcare providers. However, the current understanding of its adverse events (AEs) is fragmented. We conducted this overview to collect all systematic reviews (SRs) on the AEs of acupuncture and related therapies. MEDLINE and EMBASE were searched from inception to December 2015. Methodological quality of included reviews was assessed with a validated instrument. Evidence was narratively reported. Seventeen SRs covering various types of acupuncture were included. Methodological quality of the reviews was overall mediocre. Four major categories of AEs were identified, which are organ or tissue injuries (13 reviews, median: 36 cases, median deaths: 4), infections (11 reviews, median: 17 cases, median deaths: 0.5), local AEs or reactions (12 reviews, median: 8.5 cases, no deaths were reported), and other complications such as dizziness or syncope (11 reviews, median: 21 cases, no deaths were reported). Minor and serious AEs can occur during the use of acupuncture and related modalities, contrary to the common impression that acupuncture is harmless. Serious AEs are rare, but need significant attention as mortality can be associated with them. Referrals should consider acupuncturists' training credibility, and patient safety should be a core part of acupuncture education.
Acupuncture-related adverse events: systematic review and meta-analyses of prospective clinical studies. [2021]Overview on risks of acupuncture-related adverse events (AEs).
Safety of acupuncture by Korean Medicine Doctors: a prospective, practice-based survey of 37,490 consultations. [2022]To evaluate safety of acupuncture treatment by Korean Medicine Doctors (KMDs), a prospective, practice-based survey on adverse events (AEs) associated with acupuncture was conducted.
Adverse Events Related to Acupuncture: Development and Testing of a Rating Scale. [2016]Mild adverse events (AEs) are common with acupuncture, but the collection of AEs is generally poor. The objective of this study was to develop and test a new instrument for acupuncture-related AEs.
[Professor LAI Xinsheng's experience of acupuncture combined with medication for epilepsy]. [2018]Professor LAI Xinsheng's experience of acupuncture combined with medication for epilepsy is summarized, which is explained from epilepsy's etiology and pathogenesis, diagnosis and treatment of acupuncture and medication, respectively. Besides, the theoretical foundation and use instruction of acupuncture technique "tong-yuan" for epilepsy are introduced. Professor LAI highly values the adherence to etiology and pathogenesis, pays attention to syndrome differentiation and searches for the primary disease cause. He proposes the wind, phlegm, stasis and deficiency are the pathogenesis of epilepsy, and points out acupuncture could be applied during attack stage and remittent stage, but electroacupuncture should be used with caution. Regulating spirit is the key for treating epilepsy. The combination of acupuncture and medication could regulate the governor vessel and guide qi to the origin, which have significant curative effect.
Acupuncture for epilepsy. [2023]Acupuncture is increasingly used in people with epilepsy. It remains unclear whether existing evidence is rigorous enough to support its use. This is an update of a Cochrane review first published in 2008.
Acupuncture as an Adjunctive Treatment for Post-stroke Epilepsy: Protocol for a Randomized Controlled Trial. [2021]Background: Acupuncture has been clinically used to treat epilepsy after stroke. However, most of the current clinical studies are observational studies, and there are few well-designed randomized controlled trials (RCTs). Hence, we designed a multicentre RCT to assess the advantages and efficacy of acupuncture for post-stroke epilepsy (PSE). Methods/Design: This is a two-arm, parallel, participants-blinded and assessor-blinded and multicentre RCT. A total of 120 patients with PSE aged from 18 to 75 years will be randomly assigned to two groups (routine treatment plus acupuncture group and routine treatment plus sham acupuncture group) at a 1:1 ratio. The participants will perform acupuncture or sham acupuncture treatment three times a week and be ongoing 8-week treatment. The primary endpoint is the proportion of seizure-free patients. A safety profile will be established. We will record adverse events for the safety evaluation. Discussion: The study will provide high-quality clinical evidence on the effectiveness and safety of acupuncture for treating patients with epilepsy after stroke. Clinical Trial Registration: Chinese Clinical Trial Registry, identifier: ChiCTR2100046114.
Electroacupuncture-induced attenuation of experimental epilepsy: a comparative evaluation of acupoints and stimulation parameters. [2021]The efficacy of electroacupuncture (EA) on epilepsy remains to be verified because of previous controversies that might be due to the complexity of the effects induced by different acupoints and stimulation approaches adopted. Therefore, we investigated the effects of EA on epilepsy to determine the specific acupoints and optimal stimulation parameters in this work. Experimental epilepsy was induced by injecting kainic acid to the lateral cerebral ventricle of adult male SD rats. EA with a low-frequency (10 Hz/1 mA) or high-frequency (100 Hz/1 mA) current was applied to the epileptic model for 30 minutes starting at 0.5 hour after the injection. Four pairs of acupoints were tested, that is, Shuigou (DU26) + Dazhui (DU14), Jinsuo (DU8) + Yaoqi (EXB9), Neiguan (PC6) + Quchi (LI11), and Fenglong (ST40) + Yongquan (KI1). We found that (1) low- or high-frequency EA at different acupoints reduced epileptic seizures (P
Activation of amygdala opioid receptors by electroacupuncture of Feng-Chi (GB20) acupoints exacerbates focal epilepsy. [2021]The effect of seizure suppression by acupuncture of Feng-Chi (GB20) acupoints has been documented in the ancient Chinese literature, Lingshu Jing (Classic of the Miraculous Pivot), however, there is a lack of scientific evidence to prove it. This current study was designed to elucidate the effect of electroacupuncture (EA) stimulation of bilateral Feng-Chi (GB20) acupoints on the epileptic activity by employing an animal model of focal epilepsy.