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Transcranial Direct Current Stimulation (tDCS) as a Treatment for Acute Fear (tDCS)

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ClinicalTrials.gov Identifier: NCT02410954
Recruitment Status : Terminated
First Posted : April 8, 2015
Results First Posted : May 18, 2021
Last Update Posted : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Diagnostic
Condition Fear
Intervention Device: NeuroConn Direct Current stimulator Multiple Channel -4
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title tDCS Electrode Configuration Using tDCS to Reduce Acute Fear
Hide Arm/Group Description

Three rounds of tDCS using NeuroConn Direct Current stimulator Multiple Channel -4, Rogue Resolutions treatment optimization where each round includes identifying a promising electrode configuration based on electric field modeling using a realistic head model and capitalizing on the experience with the prior round (for rounds 2 and 3) and testing that electrode placement by administering a series of electrical doses of tDCS with that tDCS electrode configuration (carrying out a dose titration) in a cohort of 10 healthy control subjects to see if we can find an electrical dose which is well-tolerated, safe, suppresses the AOT pupil response and is below recommended current density safety limits (the safety limit in terms of Amperage varies depending on the electrode configuration)

NeuroConn Direct Current stimulator Multiple Channel -4: (tDCS) will be administered with a multichannel tDCS device that can be programmed so that the operator doesn't know the combination of electrodes being used for stimulation, and, thereby allow double-blinding. The active tDCS electrode configuration to be used will be determined with the 3 round iterative procedure described above; based on electric field modeling and personalized electrical dose titration to find the lowest dose that is well-tolerated and engages the target in terms of inhibiting the AOT pupillary response.

Administration of 7.5% CO2 to see if this elicits symptoms of Acute Fear and activates LC and whether tDCS safely inhibits the LC response to 7.5% CO2 compared with sham in a pilot cross-over trial (N=10). A 3-year double-blind, randomized, controlled trial where clinical symptoms of Acute Fear, the primary outcome are elicited with 7.5% CO2 in healthy volunteers is the final study component.

NeuroConn Direct Current stimulator Multiple Channel -4: (tDCS) will be administered with a multichannel tDCS device that can be programmed so that the operator doesn't know the combination of electrodes being used for stimulation, and, thereby allow double-blinding. The active tDCS electrode configuration to be used will be determined with the 3 round iterative procedure described above; based on electric field modeling and personalized electrical dose titration to find the lowest dose that is well-tolerated and engages the target in terms of inhibiting the AOT pupillary response.

Period Title: Overall Study
Started 14 0
Completed 0 0
Not Completed 14 0
Reason Not Completed
Unable to collect usable data due to initial protocol issues             6             0
Instrument malfunction generated unusable data             8             0
Arm/Group Title tDCS Electrode Configuration Using tDCS to Reduce Acute Fear Total
Hide Arm/Group Description

Three rounds of tDCS using NeuroConn Direct Current stimulator Multiple Channel -4, Rogue Resolutions treatment optimization where each round includes identifying a promising electrode configuration based on electric field modeling using a realistic head model and capitalizing on the experience with the prior round (for rounds 2 and 3) and testing that electrode placement by administering a series of electrical doses of tDCS with that tDCS electrode configuration (carrying out a dose titration) in a cohort of 10 healthy control subjects to see if we can find an electrical dose which is well-tolerated, safe, suppresses the AOT pupil response and is below recommended current density safety limits (the safety limit in terms of Amperage varies depending on the electrode configuration)

NeuroConn Direct Current stimulator Multiple Channel -4: (tDCS) will be administered with a multichannel tDCS device that can be programmed so that the operator doesn't know the combination of electrodes being used for stimulation, and, thereby allow double-blinding. The active tDCS electrode configuration to be used will be determined with the 3 round iterative procedure described above; based on electric field modeling and personalized electrical dose titration to find the lowest dose that is well-tolerated and engages the target in terms of inhibiting the AOT pupillary response.

Administration of 7.5% CO2 to see if this elicits symptoms of Acute Fear and activates LC and whether tDCS safely inhibits the LC response to 7.5% CO2 compared with sham in a pilot cross-over trial (N=10). A 3-year double-blind, randomized, controlled trial where clinical symptoms of Acute Fear, the primary outcome are elicited with 7.5% CO2 in healthy volunteers is the final study component.

NeuroConn Direct Current stimulator Multiple Channel -4: (tDCS) will be administered with a multichannel tDCS device that can be programmed so that the operator doesn't know the combination of electrodes being used for stimulation, and, thereby allow double-blinding. The active tDCS electrode configuration to be used will be determined with the 3 round iterative procedure described above; based on electric field modeling and personalized electrical dose titration to find the lowest dose that is well-tolerated and engages the target in terms of inhibiting the AOT pupillary response.

Total of all reporting groups
Overall Number of Baseline Participants 14 0 14
Hide Baseline Analysis Population Description
The tDCS electrode configuration study was terminated prematurely due to technical problems and delay due to a move. The Using tDCS to reduce acute fear study was never started as a result.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 0 participants 14 participants
<=18 years
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
14
 100.0%
>=65 years
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 0 participants 14 participants
Female
9
  64.3%
9
  64.3%
Male
5
  35.7%
5
  35.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 0 participants 14 participants
American Indian or Alaska Native
0
   0.0%
0
0
   0.0%
Asian
2
  14.3%
0
2
  14.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
0
   0.0%
Black or African American
3
  21.4%
0
3
  21.4%
White
9
  64.3%
0
9
  64.3%
More than one race
0
   0.0%
0
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 0 participants 14 participants
14 14
1.Primary Outcome
Title Change in VAS-A Rating
Hide Description Primary outcome will be the VAS-A "fearful" rating obtained at the end of tDCS/CO2 inhalation. AOT pupil response will be obtained every 10 minutes after the end of the tDCS/CO2 inhalation period to map the duration of persistent effects on LC.
Time Frame Every 10 min (for approximately 20 minutes) at the end of tDCS/CO2 inhalation following one week post stimulation optimization.
Hide Outcome Measure Data
Hide Analysis Population Description
No data are available to report as the instrument used malfunctioned and did not produce usable pupil measurements.
Arm/Group Title tDCS Electrode Configuration Using tDCS to Reduce Acute Fear
Hide Arm/Group Description:

Three rounds of tDCS using NeuroConn Direct Current stimulator Multiple Channel -4, Rogue Resolutions treatment optimization where each round includes identifying a promising electrode configuration based on electric field modeling using a realistic head model and capitalizing on the experience with the prior round (for rounds 2 and 3) and testing that electrode placement by administering a series of electrical doses of tDCS with that tDCS electrode configuration (carrying out a dose titration) in a cohort of 10 healthy control subjects to see if we can find an electrical dose which is well-tolerated, safe, suppresses the AOT pupil response and is below recommended current density safety limits (the safety limit in terms of Amperage varies depending on the electrode configuration)

NeuroConn Direct Current stimulator Multiple Channel -4: (tDCS) will be administered with a multichannel tDCS device that can be programmed so that the operator doesn't know the combination of electrodes being used for stimulation, and, thereby allow double-blinding. The active tDCS electrode configuration to be used will be determined with the 3 round iterative procedure described above; based on electric field modeling and personalized electrical dose titration to find the lowest dose that is well-tolerated and engages the target in terms of inhibiting the AOT pupillary response.

Administration of 7.5% CO2 to see if this elicits symptoms of Acute Fear and activates LC and whether tDCS safely inhibits the LC response to 7.5% CO2 compared with sham in a pilot cross-over trial (N=10). A 3-year double-blind, randomized, controlled trial where clinical symptoms of Acute Fear, the primary outcome are elicited with 7.5% CO2 in healthy volunteers is the final study component.

NeuroConn Direct Current stimulator Multiple Channel -4: (tDCS) will be administered with a multichannel tDCS device that can be programmed so that the operator doesn't know the combination of electrodes being used for stimulation, and, thereby allow double-blinding. The active tDCS electrode configuration to be used will be determined with the 3 round iterative procedure described above; based on electric field modeling and personalized electrical dose titration to find the lowest dose that is well-tolerated and engages the target in terms of inhibiting the AOT pupillary response.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 month
Adverse Event Reporting Description No differences
 
Arm/Group Title tDCS Electrode Configuration Using tDCS to Reduce Acute Fear
Hide Arm/Group Description

Three rounds of tDCS using NeuroConn Direct Current stimulator Multiple Channel -4, Rogue Resolutions treatment optimization where each round includes identifying a promising electrode configuration based on electric field modeling using a realistic head model and capitalizing on the experience with the prior round (for rounds 2 and 3) and testing that electrode placement by administering a series of electrical doses of tDCS with that tDCS electrode configuration (carrying out a dose titration) in a cohort of 10 healthy control subjects to see if we can find an electrical dose which is well-tolerated, safe, suppresses the AOT pupil response and is below recommended current density safety limits (the safety limit in terms of Amperage varies depending on the electrode configuration)

NeuroConn Direct Current stimulator Multiple Channel -4: (tDCS) will be administered with a multichannel tDCS device that can be programmed so that the operator doesn't know the combination of electrodes being used for stimulation, and, thereby allow double-blinding. The active tDCS electrode configuration to be used will be determined with the 3 round iterative procedure described above; based on electric field modeling and personalized electrical dose titration to find the lowest dose that is well-tolerated and engages the target in terms of inhibiting the AOT pupillary response.

Administration of 7.5% CO2 to see if this elicits symptoms of Acute Fear and activates LC and whether tDCS safely inhibits the LC response to 7.5% CO2 compared with sham in a pilot cross-over trial (N=10). A 3-year double-blind, randomized, controlled trial where clinical symptoms of Acute Fear, the primary outcome are elicited with 7.5% CO2 in healthy volunteers is the final study component.

NeuroConn Direct Current stimulator Multiple Channel -4: (tDCS) will be administered with a multichannel tDCS device that can be programmed so that the operator doesn't know the combination of electrodes being used for stimulation, and, thereby allow double-blinding. The active tDCS electrode configuration to be used will be determined with the 3 round iterative procedure described above; based on electric field modeling and personalized electrical dose titration to find the lowest dose that is well-tolerated and engages the target in terms of inhibiting the AOT pupillary response.

All-Cause Mortality
tDCS Electrode Configuration Using tDCS to Reduce Acute Fear
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/0 
Hide Serious Adverse Events
tDCS Electrode Configuration Using tDCS to Reduce Acute Fear
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
tDCS Electrode Configuration Using tDCS to Reduce Acute Fear
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/0 
Study terminated prematurely without generating any outcome data due to delays due to the study being moved from one institution to another and due to technical problems with the pupil measurements that required a long period of trouble-shooting/problem-solving and ultimately the replacement of the pupillometry device.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andrew Krystal, MD
Organization: University of California, San Francisco
Phone: (415) 476-7702
EMail: andrew.krystal@ucsf.edu
Publications:
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02410954    
Other Study ID Numbers: Pro00059590
First Submitted: February 20, 2015
First Posted: April 8, 2015
Results First Submitted: March 9, 2021
Results First Posted: May 18, 2021
Last Update Posted: May 18, 2021