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Recruiting NCT05600738

Network Effects of Therapeutic Deep Brain Stimulation

No phase Interventional Intractable Epilepsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RNS/DBS activation.
Who it may be relevant to
Registry conditions: Intractable Epilepsy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The purpose of this study is to map the acute, short-term cortical evoked responses to thalamic electrical stimulation in persons with intractable epilepsy

Interventions

  • Device RNS/DBS activation
    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.

Primary outcome measures

  • 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 )]
Secondary outcome measures (2)
  • 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)]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT05600738 · HSC-MS-22-0045

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗