Transcranial Electrical StimulationNCT06558890
Transcranial Electrical Stimulation Targeting the Cerebellum for the Treatment of Refractory Temporal Lobe Epilepsy
A study testing Transcranial Alternating Current Stimulation in people with Transcranial Electrical Stimulation and Temporal Lobe Epilepsy, run by Xijing Hospital at 1 site in China.
Trial summary
Study the therapeutic effect and potential neural mechanisms of transcranial electrical stimulation targeting the cerebellum for the treatment of refractory temporal lobe epilepsy through MRI and EEG. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Transcranial Electrical Stimulation, Temporal Lobe Epilepsy, Magnetic Resonance Imaging
- What is being tested?
- Transcranial Alternating Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years old;
- Diagnosed with refractory temporal lobe epilepsy as defined by the International League Against Epilepsy (ILAE) (failure to achieve seizure-free status after adequate trials of two appropriate antiepileptic drugs);
- Duration of epilepsy is at least 2 years, with a seizure frequency of at least 2 times per 4 weeks in the three months before enrollment;
- Taking two or more antiepileptic drugs, and continuing the same medication treatment plan during the trial period;
- Capable of cooperating to complete the treatment and related examination items;
- The patient and family members fully understand and voluntarily sign the informed consent form.
Who cannot join
- Scalp skin damage (including skin diseases or damage in the area where electrodes are applied);
- Psychogenic epilepsy or pseudo-epilepsy;
- Concurrent severe infections, cerebrovascular diseases, malignant tumors, or other diseases with severe dysfunction of major organs such as the heart, liver, and kidneys, or with mental disorders;
- Presence of any implanted devices or instruments (such as cardiac pacemakers, deep brain stimulators, cochlear implants, and vagus nerve stimulators, etc.);
- History of head trauma or other brain-related diseases;
- Pregnant or breastfeeding women;
Show all 9Show fewer
- Participation in other clinical trials at the same time;
- Changes in medication treatment plan during baseline, treatment, or follow-up period;
- Withdrawal of informed consent by the patient or family members.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital of Air Force Military Medical University
Xi'an, Shannxi
Guan Xiao, master, 18392320919, guanxiao0223@163.com
About this study
Official title: A Study on the Efficacy and Mechanism of Targeted Cerebellar Transcranial Electrical Stimulation for the Treatment of Refractory Temporal Lobe Epilepsy: A Single-center, Observational Study.
Study the therapeutic effect and potential neural mechanisms of transcranial electrical stimulation targeting the cerebellum for the treatment of refractory temporal lobe epilepsy through MRI and EEG.
Read the detailed description
This study is a single-center, observational study.This study applies transcranial alternating current stimulation to the cerebellum of patients with refractory temporal lobe epilepsy.For the recruited patients with refractory TLE (Temporal Lobe Epilepsy), they will undergo a 6-week treatment with tACS (transcranial alternating current stimulation) protocol (2mA, 10Hz, 20 minutes per side), following a schedule of treatment for 5 days - rest for 2 days - treatment for another 5 days, and then a reinforcement treatment once a week, completing a total of 14 treatments.Before treatment, at week 10, and at week 14, the frequency of epileptic seizures and the QOLIE-31 questionnaire scores will be recorded and assessed for the patients. EEG data and near-infrared spectroscopy (NIRS) brain functional imaging data will be collected before treatment and after two consecutive weeks of treatment. Magnetic resonance imaging (MRI) data will be acquired before treatment, after two consecutive weeks of treatment, and after six weeks of intensified treatment. Appropriate image processing methods and EEG processing methods will be utilized to analyze the changes in brain networks following tACS treatment, in order to explore the impact of tACS on the neural mechanisms of refractory temporal lobe epilepsy (TLE).
- Conditions
- Transcranial Electrical Stimulation, Temporal Lobe Epilepsy, Magnetic Resonance Imaging, Electroencephalogram
- Being tested
- Transcranial Alternating Current Stimulation
- Medical subject headings
- Epilepsy, Temporal Lobe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Alternating Current StimulationDevice
Transcranial Alternating Current Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Alternating Current Stimulation Intervention | Experimental | Patients with refractory TLE recruited for the study will undergo a 6-week treatment with the tACS (transcranial alternating current stimulation) protocol, which involves a 2mA current at 10Hz for 20 minutes on both sides. The treatment schedule is 5 days of treatment followed by 2 days of rest, and then another 5 days of treatment, with a weekly reinforcement treatment, for a total of 14 sessions. Receives: Device: Transcranial Alternating Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compared to baseline, the reduction rate of epileptic seizure frequency
((post-treatment - baseline) / baseline).
Measured: baseline, 10 weeks,14 weeks after treatment
Secondary outcomes (4)
Quality of Life in Epilepsy-31 (QOLIE-31) Questionnaire
The scoring method for the QOLIE-31 Questionnaire involves several key steps, as follows:1.Initial Score Calculation： the raw scores for each item on the scale can be converted to a range of 0 to 100；2.Weighted Scoring：the transformed scores are multiplied by their respective weights；3.Total Score Calculation:all the weighted scores are added together to obtain the total score. Total Score=(Emotional Symptoms Score×25+Psychological Function Score×25+Social Function Score×20+Life Domains Score×17+Additional Items Score×13)/5 In the QOLIE-31 scoring system, a higher score indicates a better quality of life for individuals with epilepsy.
Measured: baseline, 10 weeks,14 weeks after treatment
MRI measures
This study primarily applied resting-state blood oxygen level dependent functional magnetic resonance imaging (BOLD) and magnetic resonance diffusion tensor imaging (DTI) techniques to evaluate the changes in functional connectivity of the cerebellum in healthy subjects and patients before and after two weeks of transcranial electrical stimulation (TES) treatment, as well as the changes in the cerebellar cortical white matter fiber bundles two months after treatment. ALFF and ReHo analyses can reveal the characteristics of local neural activity in the brain during the resting state, and abnormal brain regions can serve as regions of interest (ROIs) for subsequent functional connectivity analysis. Additionally, the flow of cerebrospinal fluid (CSF) can be measured to reflect the functional state of the glymphatic system, which can be used to assess the therapeutic effects and the impact on lymphatic drainage function.
Measured: baseline，2weeks，14weeks after treatment
electroencephalogram(EEG)
The changes in EEG will constitute secondary research outcomes. EEG can evaluate the changes in brain functional connectivity in patients before and after transcranial electrical stimulation (TES) treatment. In addition, the alterations in the power spectrum of each frequency band, including delta, alpha, beta, theta, low gamma, and high gamma, will also be measured before and after TES treatment.
Measured: baseline，2weeks after treatment
Near-Infrared Spectroscopy (NIRS) Brain Functional Imaging
Near-Infrared Spectroscopy (NIRS) Brain Functional Imaging can assess the changes in brain function of patients before and after transcranial electrical stimulation (TES) treatment.Changes in brain functional connectivity as measured by near-infrared spectroscopy (fNIRS) imaging before and after transcranial electrical stimulation treatment.
Measured: baseline，2weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start8 Jun 2024
- Primary completion11 Aug 2024
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Transcranial Electrical StimulationStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiang Wen, Study chair, The First Affiliated Hospital of Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558890
- Sponsor's protocol ID
- KY20232387
- Status last verified
- Apr 2024
- First submitted
- 1 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Devinsky O, Vezzani A, O'Brien TJ, Jette N, Scheffer IE, de Curtis M, Perucca P. Epilepsy. Nat Rev Dis Primers. 2018 May 3;4:18024. doi: 10.1038/nrdp.2018.24.
PubMed 29722352Zoghi M, O'Brien TJ, Kwan P, Cook MJ, Galea M, Jaberzadeh S. Cathodal transcranial direct-current stimulation for treatment of drug-resistant temporal lobe epilepsy: A pilot randomized controlled trial. Epilepsia Open. 2016 Oct 17;1(3-4):130-135. doi: 10.1002/epi4.12020. eCollection 2016 Dec.
PubMed 29588936Theodore WH, Fisher RS. Brain stimulation for epilepsy. Lancet Neurol. 2004 Feb;3(2):111-8. doi: 10.1016/s1474-4422(03)00664-1.
PubMed 14747003Tergau F, Naumann U, Paulus W, Steinhoff BJ. Low-frequency repetitive transcranial magnetic stimulation improves intractable epilepsy. Lancet. 1999 Jun 26;353(9171):2209. doi: 10.1016/S0140-6736(99)01301-X. No abstract available.
PubMed 10392988Chen R, Spencer DC, Weston J, Nolan SJ. Transcranial magnetic stimulation for the treatment of epilepsy. Cochrane Database Syst Rev. 2016 Aug 11;(8):CD011025. doi: 10.1002/14651858.CD011025.pub2.
PubMed 27513825Liu A, Voroslakos M, Kronberg G, Henin S, Krause MR, Huang Y, Opitz A, Mehta A, Pack CC, Krekelberg B, Berenyi A, Parra LC, Melloni L, Devinsky O, Buzsaki G. Immediate neurophysiological effects of transcranial electrical stimulation. Nat Commun. 2018 Nov 30;9(1):5092. doi: 10.1038/s41467-018-07233-7.
PubMed 30504921Fregni F, Thome-Souza S, Nitsche MA, Freedman SD, Valente KD, Pascual-Leone A. A controlled clinical trial of cathodal DC polarization in patients with refractory epilepsy. Epilepsia. 2006 Feb;47(2):335-42. doi: 10.1111/j.1528-1167.2006.00426.x.
PubMed 16499758Antal A, Boros K, Poreisz C, Chaieb L, Terney D, Paulus W. Comparatively weak after-effects of transcranial alternating current stimulation (tACS) on cortical excitability in humans. Brain Stimul. 2008 Apr;1(2):97-105. doi: 10.1016/j.brs.2007.10.001. Epub 2007 Dec 3.
PubMed 20633376San-Juan D, Espinoza-Lopez DA, Vazquez-Gregorio R, Trenado C, Aragon MF, Perez-Perez D, Hernandez-Ruiz A, Anschel DJ. A pilot randomized controlled clinical trial of Transcranial Alternating Current Stimulation in patients with multifocal pharmaco-resistant epilepsy. Epilepsy Behav. 2022 May;130:108676. doi: 10.1016/j.yebeh.2022.108676. Epub 2022 Mar 30.
PubMed 35366528San-Juan D, Sarmiento CI, Hernandez-Ruiz A, Elizondo-Zepeda E, Santos-Vazquez G, Reyes-Acevedo G, Zuniga-Gazcon H, Zamora-Jarquin CM. Transcranial Alternating Current Stimulation: A Potential Risk for Genetic Generalized Epilepsy Patients (Study Case). Front Neurol. 2016 Nov 28;7:213. doi: 10.3389/fneur.2016.00213. eCollection 2016.
PubMed 27965623Mogul DJ, van Drongelen W. Electrical control of epilepsy. Annu Rev Biomed Eng. 2014 Jul 11;16:483-504. doi: 10.1146/annurev-bioeng-071813-104720.
PubMed 25014790Tavakoli AV, Yun K. Transcranial Alternating Current Stimulation (tACS) Mechanisms and Protocols. Front Cell Neurosci. 2017 Sep 1;11:214. doi: 10.3389/fncel.2017.00214. eCollection 2017.
PubMed 28928634Elyamany O, Leicht G, Herrmann CS, Mulert C. Transcranial alternating current stimulation (tACS): from basic mechanisms towards first applications in psychiatry. Eur Arch Psychiatry Clin Neurosci. 2021 Feb;271(1):135-156. doi: 10.1007/s00406-020-01209-9. Epub 2020 Nov 19.
PubMed 33211157Berenyi A, Belluscio M, Mao D, Buzsaki G. Closed-loop control of epilepsy by transcranial electrical stimulation. Science. 2012 Aug 10;337(6095):735-7. doi: 10.1126/science.1223154.
PubMed 22879515Streng ML, Krook-Magnuson E. The cerebellum and epilepsy. Epilepsy Behav. 2021 Aug;121(Pt B):106909. doi: 10.1016/j.yebeh.2020.106909. Epub 2020 Feb 5.
PubMed 32035793
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Efficacy and Mechanism of Targeted Cerebellar Transcranial Electrical Stimulation for the Treatment of Refractory Temporal Lobe Epilepsy: A Single-center, Observational Study.
- ClinicalTrials.gov ID
- NCT06558890
- Acronym / sponsor ID
- KY20232387
- Conditions
- Transcranial Electrical Stimulation, Temporal Lobe Epilepsy, Magnetic Resonance Imaging, Electroencephalogram
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 8 Jun 2024 (actual)
- Primary completion
- 11 Aug 2024 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Aug 2024 (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.
Study the therapeutic effect and potential neural mechanisms of transcranial electrical stimulation targeting the cerebellum for the treatment of refractory temporal lobe epilepsy through MRI and EEG.
Detailed description
This study is a single-center, observational study.This study applies transcranial alternating current stimulation to the cerebellum of patients with refractory temporal lobe epilepsy.For the recruited patients with refractory TLE (Temporal Lobe Epilepsy), they will undergo a 6-week treatment with tACS (transcranial alternating current stimulation) protocol (2mA, 10Hz, 20 minutes per side), following a schedule of treatment for 5 days - rest for 2 days - treatment for another 5 days, and then a reinforcement treatment once a week, completing a total of 14 treatments.Before treatment, at week 10, and at week 14, the frequency of epileptic seizures and the QOLIE-31 questionnaire scores will be recorded and assessed for the patients. EEG data and near-infrared spectroscopy (NIRS) brain functional imaging data will be collected before treatment and after two consecutive weeks of treatment. Magnetic resonance imaging (MRI) data will be acquired before treatment, after two consecutive weeks of treatment, and after six weeks of intensified treatment. Appropriate image processing methods and EEG processing methods will be utilized to analyze the changes in brain networks following tACS treatment, in order to explore the impact of tACS on the neural mechanisms of refractory temporal lobe epilepsy (TLE).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial Alternating Current Stimulation Intervention | Experimental | Device: Transcranial Alternating Current StimulationPatients with refractory TLE recruited for the study will undergo a 6-week treatment with the tACS (transcranial alternating current stimulation) protocol, which involves a 2mA current at 10Hz for 20 minutes on both sides. The treatment schedule is 5 days of treatment followed by 2 days of rest, and then another 5 days of treatment, with a weekly reinforcement treatment, for a total of 14 sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 65 years old;
- Diagnosed with refractory temporal lobe epilepsy as defined by the International League Against Epilepsy (ILAE) (failure to achieve seizure-free status after adequate trials of two appropriate antiepileptic drugs);
- Duration of epilepsy is at least 2 years, with a seizure frequency of at least 2 times per 4 weeks in the three months before enrollment;
- Taking two or more antiepileptic drugs, and continuing the same medication treatment plan during the trial period;
- Capable of cooperating to complete the treatment and related examination items;
Key exclusion criteria (9 listed)
- Scalp skin damage (including skin diseases or damage in the area where electrodes are applied);
- Psychogenic epilepsy or pseudo-epilepsy;
- Concurrent severe infections, cerebrovascular diseases, malignant tumors, or other diseases with severe dysfunction of major organs such as the heart, liver, and kidneys, or with mental disorders;
- Presence of any implanted devices or instruments (such as cardiac pacemakers, deep brain stimulators, cochlear implants, and vagus nerve stimulators, etc.);
- History of head trauma or other brain-related diseases;
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 |
|---|---|---|
| Transcranial Alternating Current StimulationTranscranial Alternating Current Stimulation | Device | Transcranial Alternating Current Stimulation Intervention |
Primary outcome
Compared to baseline, the reduction rate of epileptic seizure frequency
Time frame: baseline, 10 weeks,14 weeks after treatment
((post-treatment - baseline) / baseline).
4 secondary outcomes
Quality of Life in Epilepsy-31 (QOLIE-31) Questionnaire
Time frame: baseline, 10 weeks,14 weeks after treatment
MRI measures
Time frame: baseline，2weeks，14weeks after treatment
electroencephalogram(EEG)
Time frame: baseline，2weeks after treatment
Near-Infrared Spectroscopy (NIRS) Brain Functional Imaging
Time frame: baseline，2weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Background: PubMed 29722352Devinsky O, Vezzani A, O'Brien TJ, Jette N, Scheffer IE, de Curtis M, Perucca P. Epilepsy. Nat Rev Dis Primers. 2018 May 3;4:18024. doi: 10.1038/nrdp.2018.24.
- Background: PubMed 29588936Zoghi M, O'Brien TJ, Kwan P, Cook MJ, Galea M, Jaberzadeh S. Cathodal transcranial direct-current stimulation for treatment of drug-resistant temporal lobe epilepsy: A pilot randomized controlled trial. Epilepsia Open. 2016 Oct 17;1(3-4):130-135. doi: 10.1002/epi4.12020. eCollection 2016 Dec.
- Background: PubMed 14747003Theodore WH, Fisher RS. Brain stimulation for epilepsy. Lancet Neurol. 2004 Feb;3(2):111-8. doi: 10.1016/s1474-4422(03)00664-1.
- Background: PubMed 10392988Tergau F, Naumann U, Paulus W, Steinhoff BJ. Low-frequency repetitive transcranial magnetic stimulation improves intractable epilepsy. Lancet. 1999 Jun 26;353(9171):2209. doi: 10.1016/S0140-6736(99)01301-X. No abstract available.
- Background: PubMed 27513825Chen R, Spencer DC, Weston J, Nolan SJ. Transcranial magnetic stimulation for the treatment of epilepsy. Cochrane Database Syst Rev. 2016 Aug 11;(8):CD011025. doi: 10.1002/14651858.CD011025.pub2.
- Background: PubMed 30504921Liu A, Voroslakos M, Kronberg G, Henin S, Krause MR, Huang Y, Opitz A, Mehta A, Pack CC, Krekelberg B, Berenyi A, Parra LC, Melloni L, Devinsky O, Buzsaki G. Immediate neurophysiological effects of transcranial electrical stimulation. Nat Commun. 2018 Nov 30;9(1):5092. doi: 10.1038/s41467-018-07233-7.
- Background: PubMed 16499758Fregni F, Thome-Souza S, Nitsche MA, Freedman SD, Valente KD, Pascual-Leone A. A controlled clinical trial of cathodal DC polarization in patients with refractory epilepsy. Epilepsia. 2006 Feb;47(2):335-42. doi: 10.1111/j.1528-1167.2006.00426.x.
- Background: PubMed 20633376Antal A, Boros K, Poreisz C, Chaieb L, Terney D, Paulus W. Comparatively weak after-effects of transcranial alternating current stimulation (tACS) on cortical excitability in humans. Brain Stimul. 2008 Apr;1(2):97-105. doi: 10.1016/j.brs.2007.10.001. Epub 2007 Dec 3.
- Background: PubMed 35366528San-Juan D, Espinoza-Lopez DA, Vazquez-Gregorio R, Trenado C, Aragon MF, Perez-Perez D, Hernandez-Ruiz A, Anschel DJ. A pilot randomized controlled clinical trial of Transcranial Alternating Current Stimulation in patients with multifocal pharmaco-resistant epilepsy. Epilepsy Behav. 2022 May;130:108676. doi: 10.1016/j.yebeh.2022.108676. Epub 2022 Mar 30.
- Background: PubMed 27965623San-Juan D, Sarmiento CI, Hernandez-Ruiz A, Elizondo-Zepeda E, Santos-Vazquez G, Reyes-Acevedo G, Zuniga-Gazcon H, Zamora-Jarquin CM. Transcranial Alternating Current Stimulation: A Potential Risk for Genetic Generalized Epilepsy Patients (Study Case). Front Neurol. 2016 Nov 28;7:213. doi: 10.3389/fneur.2016.00213. eCollection 2016.
- Background: PubMed 25014790Mogul DJ, van Drongelen W. Electrical control of epilepsy. Annu Rev Biomed Eng. 2014 Jul 11;16:483-504. doi: 10.1146/annurev-bioeng-071813-104720.
- Background: PubMed 28928634Tavakoli AV, Yun K. Transcranial Alternating Current Stimulation (tACS) Mechanisms and Protocols. Front Cell Neurosci. 2017 Sep 1;11:214. doi: 10.3389/fncel.2017.00214. eCollection 2017.
- 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. This study is not recruiting at the moment.
Jiang Wen study chair
The First Affiliated Hospital of Air Force Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Alternating Current Stimulation in people with Transcranial Electrical Stimulation and Temporal Lobe Epilepsy, run by Xijing Hospital at 1 site in China.
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 9 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: status not confirmed, as of the sponsor's last update on 19 Aug 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guan Xiao, Master (18392320919, guanxiao0223@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compared to baseline, the reduction rate of epileptic seizure frequency (time frame: baseline, 10 weeks,14 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06558890, which also lists 15 linked publications.
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 19 Aug 2024.