Trial Outcomes & Findings for Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression (NCT NCT04366258)
NCT ID: NCT04366258
Last Updated: 2023-06-05
Results Overview
CBF is measured as Blood Oxygen Level Dependent (BOLD) signal on functional magnetic resonance imaging (fMRI). BOLD signal reflects changes in regional CBF that delineate regional activity. A positive BOLD signal marks an increase in regional blood flow, while a negative BOLD signal marks a decrease in regional blood flow. A positive percent change indicates that blood flow increased in the region of interest between scans, a negative percent change indicates blood flow decreased between scans. Approximately 60 minutes of fMRI data are recorded in the left and right dorsolateral prefrontal cortical regions of interest at each transcranial photobiomodulation (t-PBM) treatment visit, including: approximately 20 minutes prior to t-PBM administration, approximately 20 minutes coinciding with t-PBM administration, and approximately 20 minutes following t-PBM administration.
COMPLETED
NA
55 participants
20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7
2023-06-05
Participant Flow
The cross-over study enrolled 55 participants. The 31 participants who met study criteria were assigned to receive 4 irradiance dose levels of t-PBM in random order across 4 t-PBM sessions (1 dose per session, doses assigned in random order: t-PBM at High Irradiance, t-PBM at Middle Irradiance, t-PBM at Low Irradiance, and Sham).
Participant milestones
| Measure |
Patients With MDD
Participants underwent 4 Transcranial Photobiomodulation (t-PBM) treatment visits and received 1 irradiance dose per visit. The order of dose administration is randomized so patients receive each irradiance dose (50 mW/cm2; 300 mW/cm2; 770 mW/cm2), as well as a sham dose (0 mW/cm2), once over the 4 treatment visits.
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|---|---|
|
Baseline Assessments
STARTED
|
55
|
|
Baseline Assessments
COMPLETED
|
31
|
|
Baseline Assessments
NOT COMPLETED
|
24
|
|
Randomized Cross-Over
STARTED
|
31
|
|
Randomized Cross-Over
Received t-PBM at High Irradiance
|
27
|
|
Randomized Cross-Over
Received t-PBM at Medium Irradiance
|
29
|
|
Randomized Cross-Over
Received t-PBM at Low Irradiance
|
29
|
|
Randomized Cross-Over
Received t-PBM at Sham Irradiance
|
29
|
|
Randomized Cross-Over
COMPLETED
|
31
|
|
Randomized Cross-Over
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Patients With MDD
Participants underwent 4 Transcranial Photobiomodulation (t-PBM) treatment visits and received 1 irradiance dose per visit. The order of dose administration is randomized so patients receive each irradiance dose (50 mW/cm2; 300 mW/cm2; 770 mW/cm2), as well as a sham dose (0 mW/cm2), once over the 4 treatment visits.
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|---|---|
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Baseline Assessments
Screen Failure
|
21
|
|
Baseline Assessments
Early Termination
|
3
|
Baseline Characteristics
Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression
Baseline characteristics by cohort
| Measure |
Overall Study Population
n=30 Participants
All participants from whom baseline characteristics were collected.
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|---|---|
|
Age, Continuous
|
37.08 years
STANDARD_DEVIATION 15.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7CBF is measured as Blood Oxygen Level Dependent (BOLD) signal on functional magnetic resonance imaging (fMRI). BOLD signal reflects changes in regional CBF that delineate regional activity. A positive BOLD signal marks an increase in regional blood flow, while a negative BOLD signal marks a decrease in regional blood flow. A positive percent change indicates that blood flow increased in the region of interest between scans, a negative percent change indicates blood flow decreased between scans. Approximately 60 minutes of fMRI data are recorded in the left and right dorsolateral prefrontal cortical regions of interest at each transcranial photobiomodulation (t-PBM) treatment visit, including: approximately 20 minutes prior to t-PBM administration, approximately 20 minutes coinciding with t-PBM administration, and approximately 20 minutes following t-PBM administration.
Outcome measures
| Measure |
t-PBM at High Irradiance
n=27 Participants
At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2).
|
|---|---|
|
Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During High-Irradiance t-PBM
|
1.12 Percent change in raw frontal BOLD
Standard Deviation 25.07
|
PRIMARY outcome
Timeframe: 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7CBF is measured as Blood Oxygen Level Dependent (BOLD) signal on functional magnetic resonance imaging (fMRI). BOLD signal reflects changes in regional CBF that delineate regional activity. A positive BOLD signal marks an increase in regional blood flow, while a negative BOLD signal marks a decrease in regional blood flow. A positive percent change indicates that blood flow increased in the region of interest between scans, a negative percent change indicates blood flow decreased between scans. Approximately 60 minutes of fMRI data are recorded in the left and right dorsolateral prefrontal cortical regions of interest at each transcranial photobiomodulation (t-PBM) treatment visit, including: approximately 20 minutes prior to t-PBM administration, approximately 20 minutes coinciding with t-PBM administration, and approximately 20 minutes following t-PBM administration.
Outcome measures
| Measure |
t-PBM at High Irradiance
n=29 Participants
At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2).
|
|---|---|
|
Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Middle-Irradiance t-PBM
|
100.36 Percent change in raw frontal BOLD
Standard Deviation 70.72
|
PRIMARY outcome
Timeframe: 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7CBF is measured as Blood Oxygen Level Dependent (BOLD) signal on functional magnetic resonance imaging (fMRI). BOLD signal reflects changes in regional CBF that delineate regional activity. A positive BOLD signal marks an increase in regional blood flow, while a negative BOLD signal marks a decrease in regional blood flow. A positive percent change indicates that blood flow increased in the region of interest between scans, a negative percent change indicates blood flow decreased between scans. Approximately 60 minutes of fMRI data are recorded in the left and right dorsolateral prefrontal cortical regions of interest at each transcranial photobiomodulation (t-PBM) treatment visit, including: approximately 20 minutes prior to t-PBM administration, approximately 20 minutes coinciding with t-PBM administration, and approximately 20 minutes following t-PBM administration.
Outcome measures
| Measure |
t-PBM at High Irradiance
n=29 Participants
At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2).
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|---|---|
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Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Low-Irradiance t-PBM
|
-43.51 Percent change in raw frontal BOLD
Standard Deviation 25.2
|
PRIMARY outcome
Timeframe: 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7CBF is measured as Blood Oxygen Level Dependent (BOLD) signal on functional magnetic resonance imaging (fMRI). BOLD signal reflects changes in regional CBF that delineate regional activity. A positive BOLD signal marks an increase in regional blood flow, while a negative BOLD signal marks a decrease in regional blood flow. A positive percent change indicates that blood flow increased in the region of interest between scans, a negative percent change indicates blood flow decreased between scans. Approximately 60 minutes of fMRI data are recorded in the left and right dorsolateral prefrontal cortical regions of interest at each transcranial photobiomodulation (t-PBM) treatment visit, including: approximately 20 minutes prior to t-PBM administration, approximately 20 minutes coinciding with t-PBM administration, and approximately 20 minutes following t-PBM administration.
Outcome measures
| Measure |
t-PBM at High Irradiance
n=29 Participants
At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2).
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|---|---|
|
Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Sham Treatment
|
1.99 Percent change in raw frontal BOLD
Standard Deviation 30.65
|
SECONDARY outcome
Timeframe: Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7Changes computed using data recorded with magnetic resonance (MR) thermometry scans taken immediately before and after the 20-minute transcranial photobiomodulation (t-PBM) treatment administration.
Outcome measures
| Measure |
t-PBM at High Irradiance
n=8 Participants
At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2).
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|---|---|
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Change in Brain Temperature During High-Irradiance t-PBM
|
-0.38 Change in degrees (Celsius)
Standard Deviation 0.91
|
SECONDARY outcome
Timeframe: Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7Changes computed using data recorded with magnetic resonance (MR) thermometry scans taken immediately before and after the 20-minute transcranial photobiomodulation (t-PBM) treatment administration.
Outcome measures
| Measure |
t-PBM at High Irradiance
n=10 Participants
At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2).
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|---|---|
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Change in Brain Temperature During Middle-Irradiance t-PBM
|
-0.4 Change in degrees (Celsius)
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7Changes computed using data recorded with magnetic resonance (MR) thermometry scans taken immediately before and after the 20-minute transcranial photobiomodulation (t-PBM) treatment administration.
Outcome measures
| Measure |
t-PBM at High Irradiance
n=11 Participants
At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2).
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|---|---|
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Change in Brain Temperature During Low-Irradiance t-PBM
|
-0.1 Change in degrees (Celsius)
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7Changes computed using data recorded with magnetic resonance (MR) thermometry scans taken immediately before and after the 20-minute transcranial photobiomodulation (t-PBM) treatment administration.
Outcome measures
| Measure |
t-PBM at High Irradiance
n=10 Participants
At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2).
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|---|---|
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Change in Brain Temperature During Sham Treatment
|
-0.33 Change in degrees (Celsius)
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: Baseline, Follow-up (Week 8)C-SSRS systematically tracks suicidal ideation and behavior. The total score range is 0 (no ideation is present) to 5 (active suicidal ideation with specific plan and intent). The higher the score, the greater one's suicidal ideation. Any score greater than 0 is important and may indicate the need for mental health intervention.
Outcome measures
| Measure |
t-PBM at High Irradiance
n=30 Participants
At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2).
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|---|---|
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Change in Columbia Suicide Severity Rating Scale (C-SSRS) Suicide Ideation Score
|
0.07 score on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Baseline55-item self-assessment measuring severity levels of side effects. Participants rank each item on a 4-point Likert scale ranging from 0-3, where: 0 = None; 1 = Mild; 2 = Moderate; and 3 = Severe. The total score is the sum of responses. Scores range from 0 to 165; higher scores indicate greater severity of side effects
Outcome measures
| Measure |
t-PBM at High Irradiance
n=31 Participants
At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2).
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|---|---|
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Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Prior to First Treatment
|
27.81 score on a scale
Standard Deviation 11.26
|
SECONDARY outcome
Timeframe: Immediately Post-Intervention, up to Week 7 in total55-item self-assessment measuring severity levels of side effects. Participants rank each item on a 4-point Likert scale ranging from 0-3, where: 0 = None; 1 = Mild; 2 = Moderate; and 3 = Severe. The total score is the sum of responses. Scores range from 0 to 165; higher scores indicate greater severity of side effects
Outcome measures
| Measure |
t-PBM at High Irradiance
n=27 Participants
At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2).
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|---|---|
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Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following High-Irradiance t-PBM
|
21.19 score on a scale
Standard Deviation 12.04
|
SECONDARY outcome
Timeframe: Immediately Post-Intervention, up to Week 7 in total55-item self-assessment measuring severity levels of side effects. Participants rank each item on a 4-point Likert scale ranging from 0-3, where: 0 = None; 1 = Mild; 2 = Moderate; and 3 = Severe. The total score is the sum of responses. Scores range from 0 to 165; higher scores indicate greater severity of side effects
Outcome measures
| Measure |
t-PBM at High Irradiance
n=29 Participants
At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2).
|
|---|---|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Middle-Irradiance t-PBM
|
20.1 score on a scale
Standard Deviation 13.04
|
SECONDARY outcome
Timeframe: Immediately Post-Intervention, up to Week 7 in total55-item self-assessment measuring severity levels of side effects. Participants rank each item on a 4-point Likert scale ranging from 0-3, where: 0 = None; 1 = Mild; 2 = Moderate; and 3 = Severe. The total score is the sum of responses. Scores range from 0 to 165; higher scores indicate greater severity of side effects
Outcome measures
| Measure |
t-PBM at High Irradiance
n=27 Participants
At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2).
|
|---|---|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Low-Irradiance t-PBM
|
20.96 score on a scale
Standard Deviation 12.06
|
SECONDARY outcome
Timeframe: Immediately Post-Intervention, up to Week 7 in total55-item self-assessment measuring severity levels of side effects. Participants rank each item on a 4-point Likert scale ranging from 0-3, where: 0 = None; 1 = Mild; 2 = Moderate; and 3 = Severe. The total score is the sum of responses. Scores range from 0 to 165; higher scores indicate greater severity of side effects
Outcome measures
| Measure |
t-PBM at High Irradiance
n=29 Participants
At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2).
|
|---|---|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Sham Treatment
|
23.69 score on a scale
Standard Deviation 11.43
|
SECONDARY outcome
Timeframe: Immediately Post-Intervention, up to Week 7 in total3-item self-report assessment of potential inconveniences and discomforts from the transcranial photobiomodulation (t-PBM). Participants rank each item on various Likert scales. The total score is the sum of responses. Total score ranges from 3-18; higher scores indicate greater perceived inconveniences and discomforts associated with t-PBM use.
Outcome measures
| Measure |
t-PBM at High Irradiance
n=24 Participants
At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2).
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|---|---|
|
t-PBM Self-Report Questionnaire (TSRQ) Score Following High-Irradiance t-PBM
|
4.42 score on a scale
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Immediately Post-Intervention, up to Week 7 in total3-item self-report assessment of potential inconveniences and discomforts from the transcranial photobiomodulation (t-PBM). Participants rank each item on various Likert scales. The total score is the sum of responses. Total score ranges from 3-18; higher scores indicate greater perceived inconveniences and discomforts associated with t-PBM use.
Outcome measures
| Measure |
t-PBM at High Irradiance
n=28 Participants
At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2).
|
|---|---|
|
t-PBM Self-Report Questionnaire (TSRQ) Score Following Middle-Irradiance t-PBM
|
4.46 score on a scale
Standard Deviation 1.58
|
SECONDARY outcome
Timeframe: Immediately Post-Intervention, up to Week 7 in total3-item self-report assessment of potential inconveniences and discomforts from the transcranial photobiomodulation (t-PBM). Participants rank each item on various Likert scales. The total score is the sum of responses. Total score ranges from 3-18; higher scores indicate greater perceived inconveniences and discomforts associated with t-PBM use.
Outcome measures
| Measure |
t-PBM at High Irradiance
n=26 Participants
At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2).
|
|---|---|
|
t-PBM Self-Report Questionnaire (TSRQ) Score Following Low-Irradiance t-PBM
|
4.08 score on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Immediately Post-Intervention, up to Week 7 in total3-item self-report assessment of potential inconveniences and discomforts from the transcranial photobiomodulation (t-PBM). Participants rank each item on various Likert scales. The total score is the sum of responses. Total score ranges from 3-18; higher scores indicate greater perceived inconveniences and discomforts associated with t-PBM use.
Outcome measures
| Measure |
t-PBM at High Irradiance
n=26 Participants
At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2).
|
|---|---|
|
t-PBM Self-Report Questionnaire (TSRQ) Score Following Sham Treatment
|
3.77 score on a scale
Standard Deviation 1.58
|
Adverse Events
t-PBM at High Irradiance
t-PBM at Medium Irradiance
t-PBM at Low Irradiance
Sham
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
t-PBM at High Irradiance
n=27 participants at risk
At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2).
|
t-PBM at Medium Irradiance
n=26 participants at risk
At 1 of the 4 t-PBM sessions, participants were administered t-PBM at medium irradiance (500 mW/cm2).
|
t-PBM at Low Irradiance
n=28 participants at risk
At 1 of the 4 t-PBM sessions, participants were administered t-PBM at low irradiance (50 mW/cm2).
|
Sham
n=29 participants at risk
At 1 of the 4 t-PBM sessions, participants were administered t-PBM at sham irradiance (0 mW/cm2).
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Warm Skin (forehead)
|
3.7%
1/27 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
11.5%
3/26 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
14.3%
4/28 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
6.9%
2/29 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
|
Nervous system disorders
Headache
|
11.1%
3/27 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
3.8%
1/26 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
3.6%
1/28 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
0.00%
0/29 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
|
Psychiatric disorders
Insomnia
|
3.7%
1/27 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
3.8%
1/26 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
3.6%
1/28 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
6.9%
2/29 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
|
Skin and subcutaneous tissue disorders
Skin Pressure (forehead)
|
3.7%
1/27 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
0.00%
0/26 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
0.00%
0/28 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
3.4%
1/29 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
|
Psychiatric disorders
Claustrophobia
|
0.00%
0/27 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
0.00%
0/26 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
3.6%
1/28 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
0.00%
0/29 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/27 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
0.00%
0/26 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
3.6%
1/28 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
0.00%
0/29 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
|
Psychiatric disorders
Nightmares
|
0.00%
0/27 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
3.8%
1/26 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
0.00%
0/28 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
0.00%
0/29 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
|
Eye disorders
Eye Irritation
|
0.00%
0/27 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
0.00%
0/26 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
0.00%
0/28 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
3.4%
1/29 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
|
Psychiatric disorders
Confusion
|
0.00%
0/27 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
3.8%
1/26 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
0.00%
0/28 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
0.00%
0/29 • 4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place