Ignite Creation Date:
2024-05-06 @ 9:14 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02935595
Status:
COMPLETED
Last Update Posted:
2022-01-13
First Post:
2016-10-12
Brief Title:
Low Dose Intravenous Ketamine in Treatment Resistant Depression Patients
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
A Systematic Investigation of Neurophysiological Correlates of Low Dose Intravenous Ketamine in Treatment Resistant Depression Patients
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ketamine
Brief Summary:
The primary goal of the project is to study the effect of Ketamine on cortical neurophysiological function in TRD patients The proposal employs robust and non-invasive neurophysiological techniques TMS and EEG to investigate the cortical excitability and oscillatory activity in patients with treatment resistant depression
Detailed Description:
The primary goal of the project is to study the effect of Ketamine on cortical neurophysiological function in Treatment Resistant DepressionTRD patients There are three key preclinical findings regarding Ketamine antidepressant effects that motivate the current study a low dose Ketamine causes early increase in glutamate neurotransmission b Ketamine initiates synaptic plasticity c ketamine infusion leads to rapid improvement in depression symptoms The proposal essentially employs robust and non-invasive neurophysiological techniques Auditory Steady State ResponseASSR-gamma oscillatory response and Transcranial Magnetic StimulationTMS cortical excitability to investigate the above findings in patients with treatment resistant depression
Study
Ketamine Infusion
We will employ an open-label study in which the infusion session the enrolled TRD patients will receive low dose Ketamine 05 mgkg over 40 minutes
Cortical Excitability
TMS stimulation will be applied to the corresponding region of the contralateral primary motor cortex to determine motor threshold and to examine the motor cortical excitability measures after Ketamine The optimal coil position will be determined by moving the TMS coil in 1-cm increments over the motor cortical area while delivering single or paired magnetic pulses and by observing maximal contraction of the contralateral abductor pollicis brevis APB Electromyography readings will be obtained from the APB muscle TMS stimulation will then be applied to Left DLPFC or Left Brodmann Area 6 to investigate cortical excitability changes after ketamine ElectroencephalographyEEG recordings will be concurrent with TMS procedure
ASSREEG paradigm
Participants may engage in the auditory steady state response task where click trains of 500-ms duration will be presented binaurally at 65 5 decibeldB The click train repetition frequencies will be 40 Hz and presented in the context of an auditory oddball paradigm to ensure participant attention to the stimuli This task will be done while participants undergo EEG recordings
Study
Ketamine Infusion
We will employ an open-label study in which the infusion session the enrolled TRD patients will receive low dose Ketamine 05 mgkg over 40 minutes
Cortical Excitability
TMS stimulation will be applied to the corresponding region of the contralateral primary motor cortex to determine motor threshold and to examine the motor cortical excitability measures after Ketamine The optimal coil position will be determined by moving the TMS coil in 1-cm increments over the motor cortical area while delivering single or paired magnetic pulses and by observing maximal contraction of the contralateral abductor pollicis brevis APB Electromyography readings will be obtained from the APB muscle TMS stimulation will then be applied to Left DLPFC or Left Brodmann Area 6 to investigate cortical excitability changes after ketamine ElectroencephalographyEEG recordings will be concurrent with TMS procedure
ASSREEG paradigm
Participants may engage in the auditory steady state response task where click trains of 500-ms duration will be presented binaurally at 65 5 decibeldB The click train repetition frequencies will be 40 Hz and presented in the context of an auditory oddball paradigm to ensure participant attention to the stimuli This task will be done while participants undergo EEG recordings
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None