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Deep Brain Stimulation
Deep Brain Stimulation for Epilepsy
N/A
Recruiting
Led By Sandipan Pati, 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 baseline, post intervention (about 2 hours after baseline)
Awards & highlights
Study Summary
This trial studies how electrical stimulation of the thalamus affects brain activity in people with epilepsy that can't be treated with drugs.
Who is the study for?
This trial is for individuals with intractable epilepsy who are already receiving neuromodulation therapy (like DBS or RNS) and are monitored at an outpatient epilepsy clinic. It's not suitable for pregnant women, those with recent severe mental health issues, an IQ below 70, or anyone unwilling to share their medical records for research.Check my eligibility
What is being tested?
The study aims to understand the immediate brain response to thalamic electrical stimulation provided by implanted devices in patients with difficult-to-treat epilepsy. This could help improve therapeutic outcomes of deep brain stimulation.See study design
What are the potential side effects?
While the trial description does not specify side effects, typical risks of DBS/RNS activation may include discomfort at the stimulation site, temporary headache or dizziness, and a slight risk of infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, post intervention (about 2 hours after baseline )
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post intervention (about 2 hours after baseline )
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in amplitude of evoked potentials metrics as assessed by the scalp EEG
Electroencephalography
Secondary outcome measures
Change in reaction time to visual stimuli measured as vigilance score assessed by the Psychomotor Vigilance test (PVT)
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,935 Total Patients Enrolled
7 Trials studying Epilepsy
393 Patients Enrolled for Epilepsy
Sandipan Pati, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am receiving therapy with an implanted device for nerve stimulation.I have been diagnosed with epilepsy.I have not had psychosis, major depression, or suicidal thoughts in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
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.
Is there still capacity for participants in this medical trial?
"Affirmative. Clinicaltrials.gov indicates that this experiment, which was first announced on August 26th 2022, is presently recruiting participants. 25 individuals are expected to take part in the trial across one medical centre."
Answered by AI
How many participants has this research recruited thus far?
"Yes, it is accurate. Clinicaltrials.gov indicates that this medical trial opened for recruitment on August 26th 2022 and was last updated October 25th 2022. The study requires 25 participants from a single research centre to be enrolled in the experiment."
Answered by AI
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