Intractable EpilepsyNCT05600738
Network Effects of Therapeutic Deep Brain Stimulation
A study testing RNS/DBS activation in people with Intractable Epilepsy, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to map the acute, short-term cortical evoked responses to thalamic electrical stimulation in persons with intractable epilepsy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intractable Epilepsy
- What is being tested?
- RNS/DBS activation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of Epilepsy
- undergoing neuromodulation therapy with clinically implanted neuromodulation devices (DBS, RNS)
- followed in the outpatient epilepsy clinic
Who cannot join
- pregnant women
- active psychosis, major depression, or suicidal ideation in the preceding year
- Intelligence quotient (IQ) less than 70 as measured by clinical neuropsychological evaluation
- Do not agree to share their medical records for research purposes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Sandipan Pati, MD, 713-500-7925, Sandipan.Pati@uth.tmc.edu
Jaison Hampson, 713-500-7754, Jaison.S.Hampson@uth.tmc.edu
About this study
The purpose of this study is to map the acute, short-term cortical evoked responses to thalamic electrical stimulation in persons with intractable epilepsy
- Conditions
- Intractable Epilepsy
- Being tested
- RNS/DBS activation
- Keywords
- Deep brain stimulation (DBS), neuromodulation therapy, Responsive Neurostimulation (RNS)
- 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.
RNS/DBS activationDevice
This will be performed to study the EEG responses to DBS/RNS stimulation electrical pulses. The stimulation frequencies will be sequentially increased and each stimulation will last for 2 minutes.There will be a 1-2 minute wash out period after each trial.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: RNS/DBS activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in amplitude of evoked potentials metrics as assessed by the scalp EEG
Measured: Baseline, Intra intervention (about 20 minutes after baseline)
Change in amplitude of evoked potentials metrics as assessed by the scalp EEG
Measured: Baseline, post intervention (about 2 hours after baseline )
Change in latencies of evoked potentials and phase synchronization metrics recorded as assessed by the scalp EEG
Measured: Baseline, Intra intervention (about 20 minutes after baseline)
Change in latencies of evoked potentials and phase synchronization metrics recorded as assessed by the scalp EEG
Measured: Baseline, post intervention (about 2 hours after baseline )
Secondary outcomes (2)
Change in reaction time to visual stimuli measured as vigilance score assessed by the Psychomotor Vigilance test (PVT)
This is a computerized testing that will record errors in being unable to tap a switch/button
Measured: Baseline, Intra intervention (about 20 minutes after baseline)
Change in reaction time to visual stimuli measured as vigilance score assessed by the Psychomotor Vigilance test (PVT)
This is a computerized testing that will record errors in being unable to tap a switch/button
Measured: Baseline, post intervention (about 2 hours after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start26 Aug 2022
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intractable EpilepsyStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandipan Pati, MD, The University of Texas Health Science Center, Houston
- Investigators
- Sandipan Pati, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600738
- Sponsor's protocol ID
- HSC-MS-22-0045
- Status last verified
- Oct 2022
- First submitted
- 25 Oct 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Network Effects of Therapeutic Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT05600738
- Acronym / sponsor ID
- HSC-MS-22-0045
- Conditions
- Intractable Epilepsy
- Keywords
- Deep brain stimulation (DBS), neuromodulation therapy, Responsive Neurostimulation (RNS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 Oct 2022 (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 purpose of this study is to map the acute, short-term cortical evoked responses to thalamic electrical stimulation in persons with intractable epilepsy
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: RNS/DBS activation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of Epilepsy
- undergoing neuromodulation therapy with clinically implanted neuromodulation devices (DBS, RNS)
- followed in the outpatient epilepsy clinic
Key exclusion criteria (4 listed)
- pregnant women
- active psychosis, major depression, or suicidal ideation in the preceding year
- Intelligence quotient (IQ) less than 70 as measured by clinical neuropsychological evaluation
- Do not agree to share their medical records for research purposes
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 |
|---|---|---|
| RNS/DBS activationThis will be performed to study the EEG responses to DBS/RNS stimulation electrical pulses. The stimulation frequencies will be sequentially increased and each stimulation will last for 2 minutes.There will be a 1-2 minute wash out period after each trial. | Device | Treatment |
Primary outcome
Change in amplitude of evoked potentials metrics as assessed by the scalp EEG
Time frame: Baseline, Intra intervention (about 20 minutes after baseline)
Change in amplitude of evoked potentials metrics as assessed by the scalp EEG
Time frame: Baseline, post intervention (about 2 hours after baseline )
Change in latencies of evoked potentials and phase synchronization metrics recorded as assessed by the scalp EEG
Time frame: Baseline, Intra intervention (about 20 minutes after baseline)
Change in latencies of evoked potentials and phase synchronization metrics recorded as assessed by the scalp EEG
Time frame: Baseline, post intervention (about 2 hours after baseline )
2 secondary outcomes
Change in reaction time to visual stimuli measured as vigilance score assessed by the Psychomotor Vigilance test (PVT)
Time frame: Baseline, Intra intervention (about 20 minutes after baseline)
Change in reaction time to visual stimuli measured as vigilance score assessed by the Psychomotor Vigilance test (PVT)
Time frame: Baseline, post intervention (about 2 hours after baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Intractable Epilepsy
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Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy
Epilepsy
Not yet recruiting
High-Intensity Focused Ultrasonic Ablation of the Centromedian Thalamic Nucleus for Treatment of Medically Refractory Generalized Epilepsy in Patients Ages 18 Years to 89 Years
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Long-Term Epilepsy Outcomes in Children With a History of Perinatal Stroke
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Surgery as a Treatment for Medically Intractable Epilepsy
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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.
Sandipan Pati, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RNS/DBS activation in people with Intractable Epilepsy, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 31 Oct 2022. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandipan Pati, MD (713-500-7925, Sandipan.Pati@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in amplitude of evoked potentials metrics as assessed by the scalp EEG (time frame: Baseline, Intra intervention (about 20 minutes after baseline)). The study lists 4 primary outcomes in all. 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 31 Oct 2022.