Network Effects of Therapeutic Deep Brain Stimulation

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05600738

Enrollment

Registered

2022-10-31

Start date

2022-08-26

Completion date

2027-12-31

Last updated

2022-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intractable Epilepsy

Keywords

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

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

Interventions

DEVICERNS/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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change in amplitude of evoked potentials metrics as assessed by the scalp EEG	Baseline, Intra intervention (about 20 minutes after baseline)
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)

Secondary

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

Countries

United States

Contacts

Primary ContactSandipan Pati, MD

Sandipan.Pati@uth.tmc.edu713-500-7925

Backup ContactJaison Hampson

Jaison.S.Hampson@uth.tmc.edu713-500-7754

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026