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NCT Number: NCT05600738

Network Effects of Therapeutic Deep Brain Stimulation

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

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Key information

Conditions

Intractable Epilepsy Brain Diseases Central Nervous System Diseases Drug Resistant Epilepsy Epilepsy Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RNS/DBS activation

Device

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 outcomes

  1. Change in amplitude of evoked potentials metrics as assessed by the scalp EEG

    Time frame: Baseline, Intra intervention (about 20 minutes after baseline)

  2. Change in amplitude of evoked potentials metrics as assessed by the scalp EEG

    Time frame: Baseline, post intervention (about 2 hours after baseline )

  3. 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)

  4. 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 outcomes

  1. 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)

    This is a computerized testing that will record errors in being unable to tap a switch/button

  2. 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)

    This is a computerized testing that will record errors in being unable to tap a switch/button

Study contacts

Contact information is provided by the study sponsor or research team.

Jaison Hampson

CONTACT

[email protected]

713-500-7754

Sandipan Pati, MD

CONTACT

[email protected]

713-500-7925

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Oct 31, 2022
Registry last updated
Oct 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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