Tuberous Sclerosis ComplexNCT04198207
The Effectiveness and Safety of Vagus Nerve Stimulation for TRE
An observational study of Tuberous Sclerosis Complex and Epilepsy, run by Beijing Children's Hospital at 1 site in China.
Trial summary
Prospective cohort studies to identify clinical epilepsy control, cognitive changes, and safety of VNS in patients with tuberous sclerosis complex-related epilepsy. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Tuberous Sclerosis Complex, Epilepsy
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2019to 10 Dec 2024
- How long will I take part?
- 4 Years
- Phase
- Observational
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients from multiple epilepsy centers in China
Who may be able to join
- Age Range: Patients aged 1 to 18 years.
- Confirmed Diagnosis: Diagnosed with Tuberous Sclerosis Complex (TSC) according to established diagnostic criteria.
- Drug-Resistant Epilepsy: Ineffectiveness of at least two antiepileptic drugs (monotherapy or combination therapy).
- Informed Consent: Patients and their guardians understand the purpose of the study and voluntarily sign the informed consent form.
Who cannot join
- Other Severe Diseases: Presence of significant cardiovascular, respiratory, or other systemic diseases.
- Psychiatric Disorders: History or presence of severe psychiatric disorders (e.g., schizophrenia or major depressive disorder).
- Surgical Contraindications: Unsuitability for general anesthesia or factors affecting surgical safety.
- Drug Allergy: Known allergy to drugs used in the study.
- Implant Conflict: Presence of implanted medical devices that may interfere with VNS therapy.
- Pregnancy or Lactation: Pregnant or breastfeeding individuals.
- Poor Compliance: Inability to adhere to follow-up visits or treatment protocols.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Effectiveness and Safety of Vagus Nerve Stimulation for Tuberous Sclerosis Complex Related Epilepsy
Prospective cohort studies to identify clinical epilepsy control, cognitive changes, and safety of VNS in patients with tuberous sclerosis complex-related epilepsy.
Read the detailed description
This study aims to evaluate the efficacy and safety of vagus nerve stimulation (VNS) in the treatment of drug-resistant epilepsy in patients with Tuberous Sclerosis Complex (TSC) and compare it with traditional antiepileptic drug therapy. By assessing seizure frequency, severity, and improvements in quality of life, the study seeks to provide evidence-based guidance for clinical treatment strategies.
- Conditions
- Tuberous Sclerosis Complex, Epilepsy
- Keywords
- tuberous sclerosis complex, epilepsy, vagus nerve stimulation
- Medical subject headings
- Tuberous Sclerosis, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| VNS Group | VNS group: 20 patients with no localilzed epileptogenic tuber in the brain, and with VNS and multiple anti-seizure medicines. | |
| Control Group | Control group: 50 patients with no localilzed epileptogenic tuber in the brain, and with multiple anti-seizure medicines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of patients with Mchugh grading
The grading made by Mchugh for the classification of outcome with respect to epileptic seizures following epilepsy surgery. It contains a total of 5 levels. The higher the level, the worse the result. We will count the percentage of patients at each level.epileptic seizures following epilepsy surgery. It is used for assessing the control of epilepsy.
Measured: 4 years
Secondary outcomes (2)
IQ
Wechsler Intelligence Scale is used for the evaluation of IQ
Measured: 3 years
Quality of Life: QOLIE-31
QOLIE-31 is suitable for patients 14 years and older. QOLCE-76 is applied to patients aged 2-13 by parents.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start10 Dec 2019
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberous Sclerosis ComplexStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Beijing Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, The First Bethune Hospital of Jilin University, Xuanwu Hospital, Beijing, Capital Medical University, Peking University First Hospital, China-Japan Friendship Hospital, Chinese PLA General Hospital, Fourth Medical Center of PLA General Hospital, Capital Institute of Pediatrics, China, The Second Hospital of Hebei Medical University, Xijing Hospital, First Affiliated Hospital Xi'an Jiaotong University, Children's Hospital of Fudan University, RenJi Hospital, Affiliated Hospital of Jining Medical University, Xiamen Humanity Hospital, Xiangya Hospital of Central South University, Wuhan Medical Care Center for Women and Children, Guangdong 999 Brain Hospital, Shenzhen Children's Hospital, Army Medical University, China, West China Hospital
- Responsible party
- Principal investigator, Shuli Liang, Beijing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198207
- Sponsor's protocol ID
- TRE-VNS
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2019
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Effectiveness and Safety of Vagus Nerve Stimulation for Tuberous Sclerosis Complex Related Epilepsy
- ClinicalTrials.gov ID
- NCT04198207
- Acronym / sponsor ID
- TRE-VNS
- Conditions
- Tuberous Sclerosis Complex, Epilepsy
- Keywords
- tuberous sclerosis complex, epilepsy, vagus nerve stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Beijing Children's HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, The First Bethune Hospital of Jilin University, Xuanwu Hospital, Beijing, Capital Medical University, Peking University First Hospital, China-Japan Friendship Hospital, Chinese PLA General Hospital, Fourth Medical Center of PLA General Hospital, Capital Institute of Pediatrics, China, The Second Hospital of Hebei Medical University, Xijing Hospital, First Affiliated Hospital Xi'an Jiaotong University, Children's Hospital of Fudan University, RenJi Hospital, Affiliated Hospital of Jining Medical University, Xiamen Humanity Hospital, Xiangya Hospital of Central South University, Wuhan Medical Care Center for Women and Children, Guangdong 999 Brain Hospital, Shenzhen Children's Hospital, Army Medical University, China, West China Hospital
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 13 Dec 2019 (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.
Prospective cohort studies to identify clinical epilepsy control, cognitive changes, and safety of VNS in patients with tuberous sclerosis complex-related epilepsy.
Detailed description
This study aims to evaluate the efficacy and safety of vagus nerve stimulation (VNS) in the treatment of drug-resistant epilepsy in patients with Tuberous Sclerosis Complex (TSC) and compare it with traditional antiepileptic drug therapy. By assessing seizure frequency, severity, and improvements in quality of life, the study seeks to provide evidence-based guidance for clinical treatment strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VNS Group | – | –VNS group: 20 patients with no localilzed epileptogenic tuber in the brain, and with VNS and multiple anti-seizure medicines. |
| Control Group | – | –Control group: 50 patients with no localilzed epileptogenic tuber in the brain, and with multiple anti-seizure medicines. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients from multiple epilepsy centers in China
Key inclusion criteria (4 listed)
- Age Range: Patients aged 1 to 18 years.
- Confirmed Diagnosis: Diagnosed with Tuberous Sclerosis Complex (TSC) according to established diagnostic criteria.
- Drug-Resistant Epilepsy: Ineffectiveness of at least two antiepileptic drugs (monotherapy or combination therapy).
- Informed Consent: Patients and their guardians understand the purpose of the study and voluntarily sign the informed consent form.
Key exclusion criteria (7 listed)
- Other Severe Diseases: Presence of significant cardiovascular, respiratory, or other systemic diseases.
- Psychiatric Disorders: History or presence of severe psychiatric disorders (e.g., schizophrenia or major depressive disorder).
- Surgical Contraindications: Unsuitability for general anesthesia or factors affecting surgical safety.
- Drug Allergy: Known allergy to drugs used in the study.
- Implant Conflict: Presence of implanted medical devices that may interfere with VNS therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
% of patients with Mchugh grading
Time frame: 4 years
The grading made by Mchugh for the classification of outcome with respect to epileptic seizures following epilepsy surgery. It contains a total of 5 levels. The higher the level, the worse the result. We will count the percentage of patients at each level.epileptic seizures following epilepsy surgery. It is used for assessing the control of epilepsy.
2 secondary outcomes
IQ
Time frame: 3 years
Quality of Life: QOLIE-31
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberous Sclerosis Complex and Epilepsy, run by Beijing Children's 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 19 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of patients with Mchugh grading (time frame: 4 years). 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 19 Dec 2024.