Recruiting

Deep Brain Stimulation

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT05600738

Conditions

Intractable Epilepsy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RNS/DBS activation

Study Details

Brief summary:

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

Conditions

Intractable Epilepsy

Study ID

NCT05600738

Start date

Aug 26, 2022

Status verified date

Oct, 2022

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Treatment

Interventions

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 measure

  • 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 ) ]

Central Contacts and Locations

Central contacts

Sandipan Pati, MD

713-500-7925Sandipan.Pati@uth.tmc.edu

Jaison Hampson

713-500-7754Jaison.S.Hampson@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Sandipan Pati, MD

713-500-7925Sandipan.Pati@uth.tmc.edu

Jaison Hampson

713-500-7754Jaison.S.Hampson@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Oct 31, 2022

Last verified

Oct, 2022

Keywords

  • Deep brain stimulation (DBS)
  • neuromodulation therapy
  • Responsive Neurostimulation (RNS)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2022-10-31.