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Neurostimulator
Brain Stimulation for Epilepsy
N/A
Recruiting
Led By Nitin Tandon, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
Study Summary
This trial will test if a brain stimulator (DBS) can reduce seizure frequency & severity in people with a type of epilepsy that affects memory.
Who is the study for?
This trial is for adults aged 18-65 with Mesial Temporal Lobe Epilepsy who have at least 2 seizures per month but no more than an average of 3 generalized seizures monthly. Participants must speak English, have relatively good memory function, and be able to follow study procedures. Exclusions include severe cognitive impairments, certain brain abnormalities, recent serious psychiatric issues or suicide attempts, pregnancy, and incompatible metal implants.Check my eligibility
What is being tested?
The trial tests unilateral Deep Brain Stimulation (DBS) using the Medtronic Percept PC system on patients with epilepsy. It compares low frequency stimulation informed by network architecture against standard high frequency stimulation to see if it reduces seizure frequency and severity while improving memory functions.See study design
What are the potential side effects?
Potential side effects may include discomfort at the implant site, headache, dizziness or imbalance issues related to DBS therapy. There might also be risks associated with surgical implantation such as infection or bleeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of inter-ictal spikes as assessed by the Percept PC
Seizures
Seizures
+1 moreSecondary outcome measures
Verbal memory as assessed by score on the California Verbal Learning Test second edition
Verbal memory as assessed by score on the Logical Memory I and II subtests from the Wechsler Memory Scale - IV
Wellness as assessed by score on the 36-Item Short Form Health Survey (SF-36)
+2 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Site 1, then SOC, then site 2, then SOC, then site 3, then SOC, then site 4, then SOC, then site 4Experimental Treatment2 Interventions
Group II: Site 1, then SOC, then site 2, then SOC, then site 3, then SOC, then site 4, then SOC, then site 3Experimental Treatment2 Interventions
Group III: Site 1, then SOC, then site 2, then SOC, then site 3, then SOC, then site 4, then SOC, then site 2Experimental Treatment2 Interventions
Group IV: Site 1, then SOC, then site 2, then SOC, then site 3, then SOC, then site 4, then SOC, then site 1Experimental Treatment2 Interventions
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,952 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,340 Previous Clinical Trials
649,351 Total Patients Enrolled
Nitin Tandon, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
1 Previous Clinical Trials
75 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never had non-epileptic spells that could affect seizure detection.I have had a severe seizure lasting minutes or longer in the last year.I can speak and understand English.I am between 18 and 65 years old.I can understand and follow study instructions.My condition involves severe shrinkage of a major part of my hippocampus.I have memory problems due to a condition like dementia or Parkinson's.I have brain abnormalities that may be causing my epilepsy.I have not had a stroke, encephalitis, or meningitis in the last 5 years.I have had brain surgery or brain stimulation, but VNS therapy is okay if unchanged during the trial.I have at least 2 seizures a month but no more than 3 generalized seizures a month.
Research Study Groups:
This trial has the following groups:- Group 1: Site 1, then SOC, then site 2, then SOC, then site 3, then SOC, then site 4, then SOC, then site 1
- Group 2: Site 1, then SOC, then site 2, then SOC, then site 3, then SOC, then site 4, then SOC, then site 2
- Group 3: Site 1, then SOC, then site 2, then SOC, then site 3, then SOC, then site 4, then SOC, then site 3
- Group 4: Site 1, then SOC, then site 2, then SOC, then site 3, then SOC, then site 4, then SOC, then site 4
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is eligible to participate in this experiment?
"The medical team searching for 8 adult participants suffering from epilepsy must meet additional criteria, such as a cognitive IQ of 65 or higher, fluency in English and consistent seizure activity. Additionally, the patient's verbal memory must be within 1 standard deviation (SD) of the mean and they should not have more than 20 generalized seizures per year nor an average of 3 monthly before joining this 5-year study."
Answered by AI
Are there any vacancies available for participants in this research program?
"According to clinicaltrials.gov, this medical research project is not presently recruiting patients; the trial was initially made available on January 1st 2023 and its last update occurred on November 1st 2022. Despite this study's lack of recruitment activity at present, there are 240 other trials currently looking for potential participants."
Answered by AI
Is eligibility for this clinical trial limited to those under 25 years of age?
"According to the parameters of this medical trial, any participant must be between 18 and 65 years old."
Answered by AI
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