Epilepsy, Temporal LobePhase 4NCT04164056
Hippocampal and Thalamic DBS for Bilateral Temporal Lobe Epilepsy
A Phase 4 study testing deep brain stimulation in people with Epilepsy, Temporal Lobe, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The study aims to compare the safety and effectiveness of deep brain stimulation of the hippocampus and the anterior nucleus of the thalamus for reducing the frequency of seizures in patients with bilateral temporal lobe epilepsy. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Epilepsy, Temporal Lobe
- What is being tested?
- deep brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Nov 2019to Sep 2024
- Phase
- Phase 4
- 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 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients between 12 to 60 years old.
- Bilateral temporal lobe epilepsy patients proved by VEEG or SEEG.
- At least 3 seizures per month but not more than 10 seizures per month, and the longest seizure interval is no more than 30 days during the baseline.
- Patients failed to at least 3 antiepileptic drugs (AEDs), and are receiving at least 1 AEDs now.
- Be able to complete seizure diary.
- Agree to participate this study and sign informed consent.
Who cannot join
- Extratemporal lobe epilepsy or with potential extratemporal epileptogenic focus.
- Patients with psychogenic non-epileptic seizures.
- IQ < 70, or unable to complete the study.
- Patients are pregnant or plan for it.
- Patients with implanted electrical stimulation medical device.
- Patients with other severe neuropsychiatric disorders such as dementia, schizophrenia, or neurodegenerative diseases.
- Patients with cerebral lesions which unsuitable for lead implantation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Shuang Wang, MD, +86 0571-87767120, wangs77@zju.edu.cn
About this study
Official title: Hippocampal and Thalamic Deep Brain Stimulation for Bilateral Temporal Lobe Epilepsy
The study aims to compare the safety and effectiveness of deep brain stimulation of the hippocampus and the anterior nucleus of the thalamus for reducing the frequency of seizures in patients with bilateral temporal lobe epilepsy.
Read the detailed description
The outcome of resective surgery for bilateral temporal lobe epilepsy (BTLE) is poor. Neuromodulation such as deep brain stimulation is an alternative therapy for patients with drug-resistant epilepsy, especially for those not suitable for resective surgery. This prospective, randomized, open-label trial aims to compare the effectiveness of deep brain stimulation of the hippocampus and the anterior nucleus of the thalamus for bilateral temporal lobe epilepsy.
- Conditions
- Epilepsy, Temporal Lobe
- Being tested
- deep brain 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.
deep brain stimulationDevice
deep brain stimulation on the hippocampus or the anterior nucleus of the thalamus
| Study group | Role | What they receive |
|---|---|---|
| stimulation on the hippocampus | Experimental | deep brain stimulation on the hippocampus Receives: Device: deep brain stimulation |
| stimulation on the anterior nucleus of the thalamus | Active comparator | deep brain stimulation on the anterior nucleus of the thalamus Receives: Device: deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Rate
The rate of patients response to DBS, patients have at least 50% decrease in average seizure frequency after DBS are considered as responder.
Measured: 3 years after DBS
Seizure-Free Rate
The rate of patients who achieve seizure free after DBS. Patients don't have seizure for at least 1 year are considered seizure free.
Measured: 3 years after DBS
Change in Seizure Frequency
The seizure frequency after DBS compared to the seizure frequency in baseline.
Measured: 3 years after DBS
Secondary outcomes (7)
Change in Percentage of Seizure-free Days
The percentage of seizure-free days after DBS compared to the percentage of seizure-free days in baseline.
Measured: 1 year and 3 years after DBS
Change in the Maximum Length of Seizure Intervals
The maximum length of seizure intervals after DBS compared to the maximum length of seizure intervals in baseline.
Measured: 1 year and 3 years after DBS
Change in GTCS Frequency
The GTCS frequency after DBS compared to the GTCS frequency in baseline.
Measured: 1 year and 3 years after DBS
Incidence Rate of Sudden Unexplained Death in Epilepsy (SUDEP)
The Incidence Rate after DBS.
Measured: 1 year and 3 years after DBS
Change in Memory
The memory test scores after DBS compared to baseline. Wechsler memory scale (WMS, ≤51 ~ 150, higher scores mean better outcome)
Measured: 1 year and 3 years after DBS
Change in Cognitive Function
The cognitive test scores after DBS compared to baseline. Montreal Cognitive Assessment(MoCA, 0-30 scores, higher scores mean better outcome)
Measured: 1 year and 3 years after DBS
Change in Depression
The depression test scores after DBS compared to baseline. Hamilton depression scale (HAMD, 0-64 scores, lower scores mean better outcome)
Measured: 1 year and 3 years after DBS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study startNov 2019 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Epilepsy, Temporal LobeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, The Second Hospital of Hebei Medical University, Zhejiang Provincial People's Hospital
- Responsible party
- Sponsor
- Investigators
- Shuang Wang, MD, Principal investigator, Epilepsy Center, Second Affiliated Hospital, School of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164056
- Sponsor's protocol ID
- 2019-192
- Status last verified
- Oct 2019
- First submitted
- 10 Oct 2019
- Last updated
- 15 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fisher R, Salanova V, Witt T, Worth R, Henry T, Gross R, Oommen K, Osorio I, Nazzaro J, Labar D, Kaplitt M, Sperling M, Sandok E, Neal J, Handforth A, Stern J, DeSalles A, Chung S, Shetter A, Bergen D, Bakay R, Henderson J, French J, Baltuch G, Rosenfeld W, Youkilis A, Marks W, Garcia P, Barbaro N, Fountain N, Bazil C, Goodman R, McKhann G, Babu Krishnamurthy K, Papavassiliou S, Epstein C, Pollard J, Tonder L, Grebin J, Coffey R, Graves N; SANTE Study Group. Electrical stimulation of the anterior nucleus of thalamus for treatment of refractory epilepsy. Epilepsia. 2010 May;51(5):899-908. doi: 10.1111/j.1528-1167.2010.02536.x. Epub 2010 Mar 17.
PubMed 20331461Salanova V, Witt T, Worth R, Henry TR, Gross RE, Nazzaro JM, Labar D, Sperling MR, Sharan A, Sandok E, Handforth A, Stern JM, Chung S, Henderson JM, French J, Baltuch G, Rosenfeld WE, Garcia P, Barbaro NM, Fountain NB, Elias WJ, Goodman RR, Pollard JR, Troster AI, Irwin CP, Lambrecht K, Graves N, Fisher R; SANTE Study Group. Long-term efficacy and safety of thalamic stimulation for drug-resistant partial epilepsy. Neurology. 2015 Mar 10;84(10):1017-25. doi: 10.1212/WNL.0000000000001334. Epub 2015 Feb 6.
PubMed 25663221
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hippocampal and Thalamic Deep Brain Stimulation for Bilateral Temporal Lobe Epilepsy
- ClinicalTrials.gov ID
- NCT04164056
- Acronym / sponsor ID
- 2019-192
- Conditions
- Epilepsy, Temporal Lobe
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, The Second Hospital of Hebei Medical University, Zhejiang Provincial People's Hospital
- Study start
- Nov 2019 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 15 Nov 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.
The study aims to compare the safety and effectiveness of deep brain stimulation of the hippocampus and the anterior nucleus of the thalamus for reducing the frequency of seizures in patients with bilateral temporal lobe epilepsy.
Detailed description
The outcome of resective surgery for bilateral temporal lobe epilepsy (BTLE) is poor. Neuromodulation such as deep brain stimulation is an alternative therapy for patients with drug-resistant epilepsy, especially for those not suitable for resective surgery. This prospective, randomized, open-label trial aims to compare the effectiveness of deep brain stimulation of the hippocampus and the anterior nucleus of the thalamus for bilateral temporal lobe epilepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stimulation on the hippocampus | Experimental | Device: deep brain stimulationdeep brain stimulation on the hippocampus |
| stimulation on the anterior nucleus of the thalamus | Active comparator | Device: deep brain stimulationdeep brain stimulation on the anterior nucleus of the thalamus |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients between 12 to 60 years old.
- Bilateral temporal lobe epilepsy patients proved by VEEG or SEEG.
- At least 3 seizures per month but not more than 10 seizures per month, and the longest seizure interval is no more than 30 days during the baseline.
- Patients failed to at least 3 antiepileptic drugs (AEDs), and are receiving at least 1 AEDs now.
- Be able to complete seizure diary.
Key exclusion criteria (7 listed)
- Extratemporal lobe epilepsy or with potential extratemporal epileptogenic focus.
- Patients with psychogenic non-epileptic seizures.
- IQ < 70, or unable to complete the study.
- Patients are pregnant or plan for it.
- Patients with implanted electrical stimulation medical device.
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 |
|---|---|---|
| deep brain stimulationdeep brain stimulation on the hippocampus or the anterior nucleus of the thalamus | Device | stimulation on the anterior nucleus of the thalamus, stimulation on the hippocampus |
Primary outcome
Responder Rate
Time frame: 3 years after DBS
The rate of patients response to DBS, patients have at least 50% decrease in average seizure frequency after DBS are considered as responder.
Seizure-Free Rate
Time frame: 3 years after DBS
The rate of patients who achieve seizure free after DBS. Patients don't have seizure for at least 1 year are considered seizure free.
Change in Seizure Frequency
Time frame: 3 years after DBS
The seizure frequency after DBS compared to the seizure frequency in baseline.
7 secondary outcomes
Change in Percentage of Seizure-free Days
Time frame: 1 year and 3 years after DBS
Change in the Maximum Length of Seizure Intervals
Time frame: 1 year and 3 years after DBS
Change in GTCS Frequency
Time frame: 1 year and 3 years after DBS
Incidence Rate of Sudden Unexplained Death in Epilepsy (SUDEP)
Time frame: 1 year and 3 years after DBS
Change in Memory
Time frame: 1 year and 3 years after DBS
Change in Cognitive Function
Time frame: 1 year and 3 years after DBS
Change in Depression
Time frame: 1 year and 3 years after DBS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Results publication: PubMed 20331461Fisher R, Salanova V, Witt T, Worth R, Henry T, Gross R, Oommen K, Osorio I, Nazzaro J, Labar D, Kaplitt M, Sperling M, Sandok E, Neal J, Handforth A, Stern J, DeSalles A, Chung S, Shetter A, Bergen D, Bakay R, Henderson J, French J, Baltuch G, Rosenfeld W, Youkilis A, Marks W, Garcia P, Barbaro N, Fountain N, Bazil C, Goodman R, McKhann G, Babu Krishnamurthy K, Papavassiliou S, Epstein C, Pollard J, Tonder L, Grebin J, Coffey R, Graves N; SANTE Study Group. Electrical stimulation of the anterior nucleus of thalamus for treatment of refractory epilepsy. Epilepsia. 2010 May;51(5):899-908. doi: 10.1111/j.1528-1167.2010.02536.x. Epub 2010 Mar 17.
- Results publication: PubMed 25663221Salanova V, Witt T, Worth R, Henry TR, Gross RE, Nazzaro JM, Labar D, Sperling MR, Sharan A, Sandok E, Handforth A, Stern JM, Chung S, Henderson JM, French J, Baltuch G, Rosenfeld WE, Garcia P, Barbaro NM, Fountain NB, Elias WJ, Goodman RR, Pollard JR, Troster AI, Irwin CP, Lambrecht K, Graves N, Fisher R; SANTE Study Group. Long-term efficacy and safety of thalamic stimulation for drug-resistant partial epilepsy. Neurology. 2015 Mar 10;84(10):1017-25. doi: 10.1212/WNL.0000000000001334. Epub 2015 Feb 6.
- 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.
Shuang Wang, MD principal investigator
Epilepsy Center, Second Affiliated Hospital, School of Medicine, Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing deep brain stimulation in people with Epilepsy, Temporal Lobe, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 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: status not confirmed, as of the sponsor's last update on 15 Nov 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shuang Wang, MD (+86 0571-87767120, wangs77@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder Rate (time frame: 3 years after DBS). The study lists 3 primary outcomes in all. 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 NCT04164056, which also lists 2 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 15 Nov 2019.