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Network Effects of Therapeutic Deep Brain Stimulation

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ClinicalTrials.gov Identifier: NCT05600738
Recruitment Status : Recruiting
First Posted : October 31, 2022
Last Update Posted : October 31, 2022
Sponsor:
Information provided by (Responsible Party):
Sandipan Pati, MD, The University of Texas Health Science Center, Houston

Study Description
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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

Condition or disease Intervention/treatment Phase
Intractable Epilepsy Device: RNS/DBS activation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Network Effects of Therapeutic Deep Brain Stimulation
Actual Study Start Date : August 26, 2022
Estimated Primary Completion Date : July 31, 2027
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05600738


Contacts
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Contact: Sandipan Pati, MD 713-500-7925 Sandipan.Pati@uth.tmc.edu
Contact: Jaison Hampson 713-500-7754 Jaison.S.Hampson@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Sandipan Pati, MD    713-500-7925    Sandipan.Pati@uth.tmc.edu   
Contact: Jaison Hampson    713-500-7754    Jaison.S.Hampson@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Sandipan Pati, MD The University of Texas Health Science Center, Houston
More Information
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Responsible Party: Sandipan Pati, MD, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT05600738    
Other Study ID Numbers: HSC-MS-22-0045
First Posted: October 31, 2022    Key Record Dates
Last Update Posted: October 31, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Sandipan Pati, MD, The University of Texas Health Science Center, Houston:
Deep brain stimulation (DBS)
neuromodulation therapy
Responsive Neurostimulation (RNS)
Additional relevant MeSH terms:
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Drug Resistant Epilepsy
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases