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Anesthesia and Functional Connectivity: An Analysis of fMRI Changes

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ClinicalTrials.gov Identifier: NCT02196259
Recruitment Status : Terminated (Funding cessation.)
First Posted : July 22, 2014
Results First Posted : May 2, 2017
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Scott Peltier, University of Michigan

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Changes in Brain Network Connectivity
Intervention Drug: Anesthetics, Dissociative
Enrollment 16
Recruitment Details  
Pre-assignment Details 3 participants were screened out.
Arm/Group Title Initial MRI Hospital Depresssion
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The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)

Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)

[Not Specified] [Not Specified]
Period Title: Overall Study
Started 3 7 3
Completed 3 4 2
Not Completed 0 3 1
Reason Not Completed
Researcher choice             0             0             1
Partial data analysis             0             3             0
Arm/Group Title Initial MRI Initial Hospital Depression Total
Hide Arm/Group Description

The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)

Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)

The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total) The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total) Total of all reporting groups
Overall Number of Baseline Participants 3 7 3 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 7 participants 3 participants 13 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
7
 100.0%
3
 100.0%
13
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 7 participants 3 participants 13 participants
Female
1
  33.3%
1
  14.3%
0
   0.0%
2
  15.4%
Male
2
  66.7%
6
  85.7%
3
 100.0%
11
  84.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 7 participants 3 participants 13 participants
3 7 3 13
1.Primary Outcome
Title Functional Connectivity
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The imaging experiments and analysis of subject-specific data will lead to maps corresponding to separate measures: resting state functional connectivity maps. The outcome of interest is whether ketamine reduces functional connectivity between the anterior (subgenual anterior cingulate corte, sgACC) and posterior regions (posterior cingulate cortex, PCC) of the default mode network. This is the z-score of the functional connectivity correlation.

Timepoints for Initial fMRI were: Time 1:Immediately before Infusion, Time 2: After washout (Approx. 40 min after end of infusion).

Timepoints for Depression were: Time 1: 1 Day before Infusion, Time 2: 1 Day after Infusion

Time Frame 8 minutes scans, acquired between 1 day and 3 days (see above)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary outcome measure is functional connectivity as measured using the MRI scans, which is only in the Initial MRI and Depression Arms.
Arm/Group Title Initial MRI Depression
Hide Arm/Group Description:
The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)

The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)

Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)

Overall Number of Participants Analyzed 3 2
Mean (Standard Error)
Unit of Measure: z score
Before Infusion sgACC-PCC connectivity 0.3114  (0.2199) 0.3459  (0.018)
After Infusion sgACC-PCC connectivity -0.4424  (0.29) 0.3208  (0.0465)
Time Frame Subjects were followed up for possible adverse events up to 4 weeks after the final infusion session.
Adverse Event Reporting Description describe monitoring of subjects for adverse symptoms
 
Arm/Group Title Initial fMRI Hospital Depression
Hide Arm/Group Description

The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)

Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)

The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)

Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)

The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)

Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)

All-Cause Mortality
Initial fMRI Hospital Depression
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Initial fMRI Hospital Depression
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/7 (0.00%)   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Initial fMRI Hospital Depression
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/7 (0.00%)   1/3 (33.33%) 
Psychiatric disorders       
Discomfort * [1]  0/3 (0.00%)  0/7 (0.00%)  1/3 (33.33%) 
*
Indicates events were collected by non-systematic assessment
[1]
One participant reported emotional discomfort with the dissociative effects of the intervention
These data should be interpreted with caution because of the small sample size due to the nature of this pilot study.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Scott Peltier
Organization: University of Michigan
Phone: 734-647-8077
Publications:
Responsible Party: Scott Peltier, University of Michigan
ClinicalTrials.gov Identifier: NCT02196259     History of Changes
Other Study ID Numbers: U028860-MICHR-Pilot
First Submitted: July 17, 2014
First Posted: July 22, 2014
Results First Submitted: May 31, 2016
Results First Posted: May 2, 2017
Last Update Posted: May 2, 2017