Trial Outcomes & Findings for NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis (NCT NCT04638673)
NCT ID: NCT04638673
Last Updated: 2022-07-26
Results Overview
The Patient Health Questionnaire-9 (PHQ-9) is a 9-question instrument given to patients in a primary care setting to screen for the presence and severity of depression. Scores range from 0-27. Higher scores mean worse symptoms. Remission -minimal to absence of symptoms; PHQ-9 score \< 5. Response -50% or greater decrease in PHQ-9 baseline severity; residual symptoms remain. Partial Response -26% to 49% decrease in PHQ-9 baseline severity. Non-response -less than 25% decrease in PHQ-9 baseline severity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Baseline and week 4 (End of Treatment)
Results posted on
2022-07-26
Participant Flow
One participant was removed after consent for failure to satisfy all inclusion requirements.
Participant milestones
| Measure |
Active-Active Stimulation Group
This group will be randomized into the active stimulation group for weeks 1\&2 of stimulation and active stimulation during weeks 3\&4 of stimulation of study participation.
Soterix taVNS model 0125-LTE Stimulator - Active-Active Group: Participants will receive active taVNS stimulation for weeks 1-4 of the stimulation portion of this study.
|
Sham-Active Stimulation Group
This group will be randomized into the sham stimulation group for weeks 1\&2 of stimulation and active stimulation for weeks 3\&4 of stimulation of study participation.
Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group: Participants will receive sham taVNS stimulation for weeks 1\&2 and active stimulation for weeks 3\&4 of the stimulation portion of this study.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis
Baseline characteristics by cohort
| Measure |
Active-Active Stimulation Group
n=6 Participants
This group will be randomized into the active stimulation group for weeks 1\&2 of stimulation and active stimulation during weeks 3\&4 of stimulation of study participation.
Soterix taVNS model 0125-LTE Stimulator - Active-Active Group: Participants will receive active taVNS stimulation for weeks 1-4 of the stimulation portion of this study.
|
Sham-Active Stimulation Group
n=6 Participants
This group will be randomized into the sham stimulation group for weeks 1\&2 of stimulation and active stimulation for weeks 3\&4 of stimulation of study participation.
Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group: Participants will receive sham taVNS stimulation for weeks 1\&2 and active stimulation for weeks 3\&4 of the stimulation portion of this study.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.3 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
46.2 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
48.3 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 4 (End of Treatment)The Patient Health Questionnaire-9 (PHQ-9) is a 9-question instrument given to patients in a primary care setting to screen for the presence and severity of depression. Scores range from 0-27. Higher scores mean worse symptoms. Remission -minimal to absence of symptoms; PHQ-9 score \< 5. Response -50% or greater decrease in PHQ-9 baseline severity; residual symptoms remain. Partial Response -26% to 49% decrease in PHQ-9 baseline severity. Non-response -less than 25% decrease in PHQ-9 baseline severity.
Outcome measures
| Measure |
Active-Active Stimulation Group
n=6 Participants
This group will be randomized into the active stimulation group for weeks 1\&2 of stimulation and active stimulation during weeks 3\&4 of stimulation of study participation.
Soterix taVNS model 0125-LTE Stimulator - Active-Active Group: Participants will receive active taVNS stimulation for weeks 1-4 of the stimulation portion of this study.
|
Sham-Active Stimulation Group
n=6 Participants
This group will be randomized into the sham stimulation group for weeks 1\&2 of stimulation and active stimulation for weeks 3\&4 of stimulation of study participation.
Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group: Participants will receive sham taVNS stimulation for weeks 1\&2 and active stimulation for weeks 3\&4 of the stimulation portion of this study.
|
|---|---|---|
|
Change in Score of Patient Health Questionnaire-9
|
-8.7 score on a scale
Standard Deviation 6.3
|
-5.5 score on a scale
Standard Deviation 4.1
|
Adverse Events
Active-Active Stimulation Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham-Active Stimulation Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active-Active Stimulation Group
n=6 participants at risk
This group will be randomized into the active stimulation group for weeks 1\&2 of stimulation and active stimulation during weeks 3\&4 of stimulation of study participation.
Soterix taVNS model 0125-LTE Stimulator - Active-Active Group: Participants will receive active taVNS stimulation for weeks 1-4 of the stimulation portion of this study.
|
Sham-Active Stimulation Group
n=6 participants at risk
This group will be randomized into the sham stimulation group for weeks 1\&2 of stimulation and active stimulation for weeks 3\&4 of stimulation of study participation.
Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group: Participants will receive sham taVNS stimulation for weeks 1\&2 and active stimulation for weeks 3\&4 of the stimulation portion of this study.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin Irritation/Redness
|
0.00%
0/6 • 4 weeks (duration of taVNS stimulation period)
|
33.3%
2/6 • Number of events 2 • 4 weeks (duration of taVNS stimulation period)
|
Additional Information
Dr. Mark S. George
Medical University of South Carolina
Phone: 843-876-5142
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place