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Network Effects of Therapeutic Deep Brain Stimulation

Primary Purpose

Intractable Epilepsy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RNS/DBS activation
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Intractable Epilepsy focused on measuring Deep brain stimulation (DBS), neuromodulation therapy, Responsive Neurostimulation (RNS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Outcomes

Primary Outcome Measures

Change in amplitude of evoked potentials metrics as assessed by the scalp EEG
Change in amplitude of evoked potentials metrics as assessed by the scalp EEG
Change in latencies of evoked potentials and phase synchronization metrics recorded as assessed by the scalp EEG
Change in latencies of evoked potentials and phase synchronization metrics recorded as assessed by the scalp EEG

Secondary Outcome Measures

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
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

Full Information

First Posted
October 25, 2022
Last Updated
October 25, 2022
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT05600738
Brief Title
Network Effects of Therapeutic Deep Brain Stimulation
Official Title
Network Effects of Therapeutic Deep Brain Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 26, 2022 (Actual)
Primary Completion Date
July 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intractable Epilepsy
Keywords
Deep brain stimulation (DBS), neuromodulation therapy, Responsive Neurostimulation (RNS)

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
RNS/DBS activation
Intervention Description
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 Information:
Title
Change in amplitude of evoked potentials metrics as assessed by the scalp EEG
Time Frame
Baseline, Intra intervention (about 20 minutes after baseline)
Title
Change in amplitude of evoked potentials metrics as assessed by the scalp EEG
Time Frame
Baseline, post intervention (about 2 hours after baseline )
Title
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)
Title
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 Measure Information:
Title
Change in reaction time to visual stimuli measured as vigilance score assessed by the Psychomotor Vigilance test (PVT)
Description
This is a computerized testing that will record errors in being unable to tap a switch/button
Time Frame
Baseline, Intra intervention (about 20 minutes after baseline)
Title
Change in reaction time to visual stimuli measured as vigilance score assessed by the Psychomotor Vigilance test (PVT)
Description
This is a computerized testing that will record errors in being unable to tap a switch/button
Time Frame
Baseline, post intervention (about 2 hours after baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandipan Pati, MD
Phone
713-500-7925
Email
Sandipan.Pati@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jaison Hampson
Phone
713-500-7754
Email
Jaison.S.Hampson@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandipan Pati, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandipan Pati, MD
Phone
713-500-7925
Email
Sandipan.Pati@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Jaison Hampson
Phone
713-500-7754
Email
Jaison.S.Hampson@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Network Effects of Therapeutic Deep Brain Stimulation

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