Network Effects of Therapeutic Deep Brain Stimulation

Not Applicable

Recruiting

• Conditions: Intractable Epilepsy
• Interventions: Device: RNS/DBS activation

• Registration Number: NCT05600738
• Lead Sponsor: The University of Texas Health Science Center, Houston

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-26
• Status Verified: 2022-10
• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-10-25
• Last Update Submitted: 2022-10-25
• Study First Posted: 2022-10-31
• Last Update Posted: 2022-10-31
• Primary Completion: 2027-07-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	RNS/DBS activation	-

Primary Outcome Measures

Name	Time	Method
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, post intervention (about 2 hours after baseline )

Secondary Outcome Measures

Name	Time	Method
Change in reaction time to visual stimuli measured as vigilance score assessed by the Psychomotor Vigilance test (PVT)	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

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States