Network Effects of Therapeutic Deep Brain Stimulation

Intractable Epilepsy Clinical Trial

Official title:

Network Effects of Therapeutic Deep Brain Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05600738
• Other study ID #: HSC-MS-22-0045
• Status: Recruiting
• Phase: N/A
• Start date: August 26, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: October 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: Sandipan Pati, MD
• Phone: 713-500-7925
• Email: Sandipan.Pati[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 31, 2027
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Intractable Epilepsy

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in amplitude of evoked potentials metrics as assessed by the scalp EEG		Baseline, Intra intervention (about 20 minutes after baseline)
Primary	Change in amplitude of evoked potentials metrics as assessed by the scalp EEG		Baseline, post intervention (about 2 hours after baseline )
Primary	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)
Primary	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	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)
Secondary	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)