Epilepsy (treatment Refractory)NCT06593444
Thalamic Ventral Intermediate Electrical Stimulation for Refractory Familial Cortical Myoclonus with Epilepsy
A study testing Thalamic Ventral Intermediate-DBS in people with Epilepsy (treatment Refractory), run by Xuanwu Hospital, Beijing.
Trial summary
The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of Thalamic Ventral Intermediate as adjunctive therapy for alleviating symptoms in refractory familial cortical myoclonus with epilepsy. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Epilepsy (treatment Refractory)
- What is being tested?
- Thalamic Ventral Intermediate-DBS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2024to 20 Sep 2025
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 30-70, meeting the diagnostic criteria for Refractory Familial Cortical Myoclonus with Epilepsy (FCMTE), meaning that tremors and/or seizures have not significantly improved despite long-term, stable use of current treatment medications, regardless of gender.
- Tremors and seizures severely impact the patients\' work and quality of life.
- Experiencing drug resistance or intolerable adverse reactions to medication.
- After being adequately informed about the nature and risks of the study, willing to provide written informed consent before participating in any study-related procedures.
- Willing to adhere to the relevant trial protocol and regulations, including attending follow-up visits and undergoing related examinations within the specified timeframe.
Who cannot join
- Patients with FCMTE whose symptoms are essentially controlled after standardized medication and other treatments.
- Presence of structural abnormalities in the VIM (ventral intermediate nucleus).
- Presence of an implanted electrical stimulator (e.g., pacemaker, spinal cord stimulator, repetitive nerve stimulator) or metallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagus nerve stimulation (with stable parameters for at least 3 months) is not an exclusion criterion.
- IQ \< 55, severe cognitive impairment that prevents participation in the study.
- Pregnant individuals or those planning to conceive within 2 years.
- Presence of progressive neurological diseases such as brain tumors, arteriovenous malformations, or cavernous hemangiomas.
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- Presence of other serious neuropsychiatric disorders such as dementia, severe depression (hospitalized in a psychiatric facility within the past 5 years or any suicidal or self-harming tendencies), schizophrenia, or neurodegenerative diseases. Resolved postictal psychiatric or behavioral abnormalities are not an exclusion criterion.
- Conditions that may increase the risk of seizures during or after surgery (e.g., coagulation disorders) or require long-term oral anticoagulants or antiplatelet drugs.
- Other severe physical illnesses, psychiatric disorders, internal diseases, or severe liver or kidney dysfunction; participation in other clinical trials within the past three months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Efficacy and Safety of Thalamic Ventral Intermediate Electrical Stimulation for Refractory Familial Cortical Myoclonus with Epilepsy: a Prospective, Pilot Trial
The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of Thalamic Ventral Intermediate as adjunctive therapy for alleviating symptoms in refractory familial cortical myoclonus with epilepsy.
Read the detailed description
This project aims to include 5 participants, and evaluate the effectiveness and safety of Thalamic Ventral Intermediate electrical stimulation in patients with refractory familial cortical myoclonus with epilepsy through a prospective, interventional, unblinded, single-arm clinical trial. It is expected to provide new therapeutic options for patients with refractory familial cortical myoclonus with epilepsy with alternative treatment options.
- Conditions
- Epilepsy (treatment Refractory)
- Being tested
- Thalamic Ventral Intermediate-DBS
- Keywords
- Deep Brain Stimulation, Thalamic Ventral Intermediate, Refractory Familial Cortical Myoclonus with Epilepsy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thalamic Ventral Intermediate-DBSProcedure or surgery
Participants will undergo Thalamic Ventral Intermediate-DBS ON with the individual stimulation parameters determined in the parameter determination period, then continue to receive stimulation for the remainder of the study.
| Study group | Role | What they receive |
|---|---|---|
| Thalamic Ventral Intermediate-DBS group | Experimental | Participants will undergo Thalamic Ventral Intermediate-DBS ON with the individual stimulation parameters determined in the parameter determination period, then continue to receive stimulation for the remainder of the study. Receives: Procedure: Thalamic Ventral Intermediate-DBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Tremors
A difference in tremor severity before and after treatment according to the TETRAS scale has been observed.
Measured: Up to 3 months after Thalamic Ventral Intermediate-DBS
Secondary outcomes (2)
Seizure Responder Rate
The proportion of patients with a ≥ 50% reduction from Baseline in seizure frequency.
Measured: Up to 3 months after Thalamic Ventral Intermediate-DBS
Life quality evaluation
Percentage change from baseline in Quality of Life in Epilepsy-31 inventory (QOLIE-31) score. The minimum and maximum values, and whether higher scores mean a better or worse outcome.
Measured: Up to 3 months after Thalamic Ventral Intermediate-DBS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Sep 2024 (estimated)
- Primary completion20 Mar 2025 (estimated)
- Study completion20 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy (treatment Refractory)Studies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liankun_Ren, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593444
- Sponsor's protocol ID
- 2024-213-003
- Status last verified
- Sep 2024
- First submitted
- 9 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Thalamic Ventral Intermediate Electrical Stimulation for Refractory Familial Cortical Myoclonus with Epilepsy: a Prospective, Pilot Trial
- ClinicalTrials.gov ID
- NCT06593444
- Acronym / sponsor ID
- 2024-213-003
- Conditions
- Epilepsy (treatment Refractory)
- Keywords
- Deep Brain Stimulation, Thalamic Ventral Intermediate, Refractory Familial Cortical Myoclonus with Epilepsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 20 Sep 2024 (estimated)
- Primary completion
- 20 Mar 2025 (estimated)
- Study completion
- 20 Sep 2025 (estimated)
- First posted
- 19 Sep 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.
The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of Thalamic Ventral Intermediate as adjunctive therapy for alleviating symptoms in refractory familial cortical myoclonus with epilepsy.
Detailed description
This project aims to include 5 participants, and evaluate the effectiveness and safety of Thalamic Ventral Intermediate electrical stimulation in patients with refractory familial cortical myoclonus with epilepsy through a prospective, interventional, unblinded, single-arm clinical trial. It is expected to provide new therapeutic options for patients with refractory familial cortical myoclonus with epilepsy with alternative treatment options.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thalamic Ventral Intermediate-DBS group | Experimental | Procedure: Thalamic Ventral Intermediate-DBSParticipants will undergo Thalamic Ventral Intermediate-DBS ON with the individual stimulation parameters determined in the parameter determination period, then continue to receive stimulation for the remainder of the study. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 30-70, meeting the diagnostic criteria for Refractory Familial Cortical Myoclonus with Epilepsy (FCMTE), meaning that tremors and/or seizures have not significantly improved despite long-term, stable use of current treatment medications, regardless of gender.
- Tremors and seizures severely impact the patients\' work and quality of life.
- Experiencing drug resistance or intolerable adverse reactions to medication.
- After being adequately informed about the nature and risks of the study, willing to provide written informed consent before participating in any study-related procedures.
- Willing to adhere to the relevant trial protocol and regulations, including attending follow-up visits and undergoing related examinations within the specified timeframe.
Key exclusion criteria (9 listed)
- Patients with FCMTE whose symptoms are essentially controlled after standardized medication and other treatments.
- Presence of structural abnormalities in the VIM (ventral intermediate nucleus).
- Presence of an implanted electrical stimulator (e.g., pacemaker, spinal cord stimulator, repetitive nerve stimulator) or metallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagus nerve stimulation (with stable parameters for at least 3 months) is not an exclusion criterion.
- IQ \< 55, severe cognitive impairment that prevents participation in the study.
- Pregnant individuals or those planning to conceive within 2 years.
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 |
|---|---|---|
| Thalamic Ventral Intermediate-DBSParticipants will undergo Thalamic Ventral Intermediate-DBS ON with the individual stimulation parameters determined in the parameter determination period, then continue to receive stimulation for the remainder of the study. | Procedure or surgery | Thalamic Ventral Intermediate-DBS group |
Primary outcome
Severity of Tremors
Time frame: Up to 3 months after Thalamic Ventral Intermediate-DBS
A difference in tremor severity before and after treatment according to the TETRAS scale has been observed.
2 secondary outcomes
Seizure Responder Rate
Time frame: Up to 3 months after Thalamic Ventral Intermediate-DBS
Life quality evaluation
Time frame: Up to 3 months after Thalamic Ventral Intermediate-DBS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 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.
Questions about this trial
What is this clinical trial studying?
A study testing Thalamic Ventral Intermediate-DBS in people with Epilepsy (treatment Refractory), run by Xuanwu Hospital, Beijing.
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 5 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 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Liankun Ren (13681576621, renlk2022@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Tremors (time frame: Up to 3 months after Thalamic Ventral Intermediate-DBS). 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 Sep 2024.