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

Study Overview

• Status: Recruiting
• Conditions: Intractable Epilepsy
• Intervention / Treatment: Device: RNS/DBS activation

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sandipan Pati, MD; Phone Number: 713-500-7925; Email: Sandipan.Pati@uth.tmc.edu
• Study Contact Backup: Name: Jaison Hampson; Phone Number: 713-500-7754; Email: Jaison.S.Hampson@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Sandipan Pati, MD; Phone Number: 713-500-7925; Email: Sandipan.Pati@uth.tmc.edu
      • Contact: Jaison Hampson; Phone Number: 713-500-7754; Email: Jaison.S.Hampson@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in amplitude of evoked potentials metrics as assessed by the scalp EEG	Baseline, Intra intervention (about 20 minutes after baseline)
Change in amplitude of evoked potentials metrics as assessed by the scalp EEG	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	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	Baseline, post intervention (about 2 hours after baseline )

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in reaction time to visual stimuli measured as vigilance score assessed by the Psychomotor Vigilance test (PVT)	This is a computerized testing that will record errors in being unable to tap a switch/button	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)	This is a computerized testing that will record errors in being unable to tap a switch/button	Baseline, post intervention (about 2 hours after baseline)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Sandipan Pati, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2022
• Primary Completion (Anticipated): July 31, 2027
• Study Completion (Anticipated): December 31, 2027

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Deep brain stimulation (DBS); neuromodulation therapy; Responsive Neurostimulation (RNS)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Drug Resistant Epilepsy
• Other Study ID Numbers: HSC-MS-22-0045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No