Refractory EpilepsyANT-DBS-RENCT02602899
Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Refractory Epilepsy
A study testing PINS'Deep Brain Stimulator device in people with Refractory Epilepsy, run by Beijing Pins Medical Co., Ltd at 1 site in China.
Trial summary
Evaluate the long-term clinical effectiveness and safety of the PINS Deep Brain Stimulation to patients with refractory epilepsy. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Refractory Epilepsy
- What is being tested?
- PINS'Deep Brain Stimulator device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Dec 2017
- 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 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 12-60.
- having tried at least two appropriate anti-epileptic drugs (AEDs) tested to tolerance or to blood levels at upper end of the target range of which at least 2 have been tolerated at normal dose.
- at least 6 seizures per month.
- in good health except epilepsy.
- to with normal MMSE score
- patients or his(her) familys could understand this method and sign the informed consent 7）Patients with good compliance and could complete postoperative follow-up
Who cannot join
- results of MRI remind epilepsy caused by intracranial space-occupying lesions.
- the vagus nerve lesion and damage
- tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，peptic ulcer，diabetes Type 1，bad health etc, and other surgical contraindication.
Trial locations and contacts
1 site in 1 country.
Luming Li contact
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100050
Jianguo Zhang, MD, 010-67096611, Limuxin2011@163.com
About this study
Evaluate the long-term clinical effectiveness and safety of the PINS Deep Brain Stimulation to patients with refractory epilepsy.
- Conditions
- Refractory Epilepsy
- Being tested
- PINS'Deep Brain Stimulator device
- Keywords
- PINS, Deep Brain Stimulator, Refractory Epilepsy, Anterior Thalamic Nucleus
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PINS'Deep Brain Stimulator deviceProcedure or surgery
deep brain stimulation of the PINS'IPG function to anterior nucleus of the thalamus is off in a short time
| Study group | Role | What they receive |
|---|---|---|
| PINS Deep Brain Stimulator | Experimental | Deep Brain Stimulator is on,continuous stimulation to the brain, Receives: Procedure: PINS'Deep Brain Stimulator device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in seizure frequency from baseline to the seizure count evaluation period 6 month
Measured: 6 month of stimulation
Secondary outcomes (4)
Changes in seizure frequency from baseline to the seizure count evaluation period
Measured: 1,3,6,12 months of stimulation
Overall Quality of Life in Epilepsy-31 (QOLIE-31) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment
Measured: Mean change from baseline QOLIE-31 Overall Score at 1,3,6,12 months
Change in the Number of Anti-epileptic Drugs Prescribed
Measured: At 1,3,6,12 months
Change from Baseline in the Engel and McHugh description
Measured: At 1,3,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startApr 2015
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory EpilepsyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Pins Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Sponsor
- Investigators
- Luming Li, Study chair, study principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602899
- Sponsor's protocol ID
- PINS-013
- Acronym
- ANT-DBS-RE
- Status last verified
- Oct 2016
- First submitted
- 10 Oct 2015
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Refractory Epilepsy
- ClinicalTrials.gov ID
- NCT02602899
- Acronym / sponsor ID
- ANT-DBS-RE / PINS-013
- Conditions
- Refractory Epilepsy
- Keywords
- PINS, Deep Brain Stimulator, Refractory Epilepsy, Anterior Thalamic Nucleus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing Pins Medical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital
- Study start
- Apr 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 11 Nov 2015 (estimated)
- 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.
Evaluate the long-term clinical effectiveness and safety of the PINS Deep Brain Stimulation to patients with refractory epilepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PINS Deep Brain Stimulator | Experimental | Procedure: PINS'Deep Brain Stimulator deviceDeep Brain Stimulator is on,continuous stimulation to the brain, |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- age 12-60.
- having tried at least two appropriate anti-epileptic drugs (AEDs) tested to tolerance or to blood levels at upper end of the target range of which at least 2 have been tolerated at normal dose.
- at least 6 seizures per month.
- in good health except epilepsy.
- to with normal MMSE score
Key exclusion criteria (3 listed)
- results of MRI remind epilepsy caused by intracranial space-occupying lesions.
- the vagus nerve lesion and damage
- tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，peptic ulcer，diabetes Type 1，bad health etc, and other surgical contraindication.
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 |
|---|---|---|
| PINS'Deep Brain Stimulator devicedeep brain stimulation of the PINS'IPG function to anterior nucleus of the thalamus is off in a short time | Procedure or surgery | PINS Deep Brain Stimulator |
Primary outcome
Changes in seizure frequency from baseline to the seizure count evaluation period 6 month
Time frame: 6 month of stimulation
4 secondary outcomes
Changes in seizure frequency from baseline to the seizure count evaluation period
Time frame: 1,3,6,12 months of stimulation
Overall Quality of Life in Epilepsy-31 (QOLIE-31) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment
Time frame: Mean change from baseline QOLIE-31 Overall Score at 1,3,6,12 months
Change in the Number of Anti-epileptic Drugs Prescribed
Time frame: At 1,3,6,12 months
Change from Baseline in the Engel and McHugh description
Time frame: At 1,3,6,12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
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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.
Luming Li contact
Luming Li study chair
study principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PINS'Deep Brain Stimulator device in people with Refractory Epilepsy, run by Beijing Pins Medical Co., Ltd 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 3 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 12 Dec 2016. 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 Fumin Jia (+86 010-59361265, pins_medical@163.con), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in seizure frequency from baseline to the seizure count evaluation period 6 month (time frame: 6 month of stimulation). 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 12 Dec 2016.