Network Effects of Therapeutic Deep Brain Stimulation

NCT ID: NCT05600738

Last Updated: 2022-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-26

Study Completion Date

2027-12-31

Brief Summary

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

Detailed Description

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Conditions

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Intractable Epilepsy

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment

Group Type EXPERIMENTAL

RNS/DBS activation

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Sandipan Pati, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sandipan Pati, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sandipan Pati, MD

Role: CONTACT

Phone: 713-500-7925

Email: [email protected]

Jaison Hampson

Role: CONTACT

Phone: 713-500-7754

Email: [email protected]

Facility Contacts

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Sandipan Pati, MD

Role: primary

Jaison Hampson

Role: backup

Other Identifiers

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HSC-MS-22-0045

Identifier Type: -

Identifier Source: org_study_id