Network Effects of Therapeutic Deep Brain Stimulation for Intractable Epilepsy

This study is looking at how Deep Brain Stimulation (DBS) or Responsive Neurostimulation (RNS) affects the brain in people with epilepsy that hasn't responded to other treatments (intractable epilepsy). Researchers will activate your implanted DBS or RNS device and study your brain's electrical responses using an electroencephalogram (EEG), which measures brain waves. They want to see how the strength and timing of these brain responses change during and shortly after stimulation. You might be able to join if you have epilepsy, already have a DBS or RNS device, and are seen at an outpatient epilepsy clinic. The study aims to enroll 25 participants, but its current recruitment status is unclear.

Study design
This is an interventional study involving 25 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo RNS/DBS activation, with stimulation frequencies sequentially increased. Each stimulation lasts 2 minutes, with a 1-2 minute washout period after each trial.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at baseline, during the intervention (about 20 minutes after baseline), and post-intervention (about 2 hours after baseline).

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NCT05600738

Network Effects of Therapeutic Deep Brain Stimulation

Recruiting
NAAges 18+InterventionalBasic science
The University of Texas Health Science Center, Houston
~25 participants
Updated 2022-10-31 on ClinicalTrials.gov
What's tested:RNS/DBS activation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in amplitude of evoked potentials metrics as assessed by the scalp EEG
Measured over Baseline, Intra intervention (about 20 minutes after baseline)
+3 more outcomes measured
Intractable Epilepsy
1 sites across 1 states
Texas1
  • Sandipan Pati, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

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Eligibility criteria

Inclusion

diagnosis of Epilepsy
undergoing neuromodulation therapy with clinically implanted neuromodulation devices (DBS, RNS)
followed in the outpatient epilepsy clinic

Exclusion

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
  • Change in amplitude of evoked potentials metrics as assessed by the scalp EEGBaseline, Intra intervention (about 20 minutes after baseline)
  • Change in amplitude of evoked potentials metrics as assessed by the scalp EEGBaseline, post intervention (about 2 hours after baseline )
  • Change in latencies of evoked potentials and phase synchronization metrics recorded as assessed by the scalp EEGBaseline, Intra intervention (about 20 minutes after baseline)
  • Change in latencies of evoked potentials and phase synchronization metrics recorded as assessed by the scalp EEGBaseline, post intervention (about 2 hours after baseline )