Network Effects of Therapeutic Deep Brain Stimulation
1 other identifier
interventional
25
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 26, 2022
CompletedFirst Submitted
Initial submission to the registry
October 25, 2022
CompletedFirst Posted
Study publicly available on registry
October 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
October 31, 2022
October 1, 2022
4.9 years
October 25, 2022
October 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change in amplitude of evoked potentials metrics as assessed by the scalp EEG
Baseline, Intra intervention (about 20 minutes after baseline)
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, 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, post intervention (about 2 hours after baseline )
Secondary Outcomes (2)
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)
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)
Study Arms (1)
Treatment
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- diagnosis of Epilepsy
- undergoing neuromodulation therapy with clinically implanted neuromodulation devices (DBS, RNS)
- followed in the outpatient epilepsy clinic
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandipan Pati, MD
The University of Texas Health Science Center, Houston
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 25, 2022
First Posted
October 31, 2022
Study Start
August 26, 2022
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
October 31, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share