Trial Outcomes & Findings for Transcranial Laser Therapy, Continuous and Pulsed Light, for Major Depressive Disorder (ELATED-3) (NCT NCT02959307)
NCT ID: NCT02959307
Last Updated: 2020-09-21
Results Overview
This is a brief (16-item) clinician-rated inventory of core depressive symptoms such as sleep, depressed mood, appetite, concentration, suicidal ideation, interest, energy, psychomotor retardation or agitation. Scores range from 0-27, higher scores indicating greater depression severity.
COMPLETED
NA
49 participants
6 weeks - Sequential-parallel comparison design
2020-09-21
Participant Flow
Participant milestones
| Measure |
Transcranial Light Therapy
Transcranial light therapy penetrates the skin and brain using light energy and, the light energy may activate under-stimulated brain regions.
Transcranial Light Therapy: Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.
|
Sham Transcranial Light Therapy
For the sham group, The transcranial light therapy device uses nonpenetrating light emitting diode light energy. The sham controls for which participants improve from the actual transcranial light therapy treatment and which participants improve during the study for reasons other than the therapy
Transcranial Light Therapy: Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.
Sham Transcranial Light Therapy: The same device used for the actual transcranial light therapy is used as the sham device; The device, when set to sham, will mimic the actual transcranial light therapy; however, when set to sham the device does not emit skin and cranium penetrating light emitting diode light energy.
|
|---|---|---|
|
Phase 1
STARTED
|
18
|
31
|
|
Phase 1
COMPLETED
|
15
|
23
|
|
Phase 1
NOT COMPLETED
|
3
|
8
|
|
Phase 2
STARTED
|
28
|
10
|
|
Phase 2
COMPLETED
|
26
|
10
|
|
Phase 2
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transcranial Laser Therapy, Continuous and Pulsed Light, for Major Depressive Disorder (ELATED-3)
Baseline characteristics by cohort
| Measure |
Transcranial Light Therapy
n=18 Participants
Transcranial light therapy penetrates the skin and brain using light energy and, the light energy may activate under-stimulated brain regions.
Transcranial Light Therapy: Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.
|
Sham Transcranial Light Therapy
n=31 Participants
For the sham group, The transcranial light therapy device uses nonpenetrating light emitting diode light energy. The sham controls for which participants improve from the actual transcranial light therapy treatment and which participants improve during the study for reasons other than the therapy
Transcranial Light Therapy: Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.
Sham Transcranial Light Therapy: The same device used for the actual transcranial light therapy is used as the sham device; The device, when set to sham, will mimic the actual transcranial light therapy; however, when set to sham the device does not emit skin and cranium penetrating light emitting diode light energy.
|
Total
n=49 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
37.222 years
STANDARD_DEVIATION 15.509 • n=5 Participants
|
42.806 years
STANDARD_DEVIATION 15.823 • n=7 Participants
|
40.755 years
STANDARD_DEVIATION 16.137 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
|
Age of Depressive Onset
|
17.294 years
STANDARD_DEVIATION 9.973 • n=5 Participants
|
23.429 years
STANDARD_DEVIATION 16.089 • n=7 Participants
|
21.111 years
STANDARD_DEVIATION 14.285 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks - Sequential-parallel comparison designPopulation: Sham Group in Phase 1 accounts for all subjects Receiving Sham. Patients in Sham within the first phase would be re-randomized to either NIR or Sham after completion of the initial 6 weeks. 2 participants in Sham did not have scores collected, as such the Sham group for Phase 1 consists of 29 participants rather than the total 31.
This is a brief (16-item) clinician-rated inventory of core depressive symptoms such as sleep, depressed mood, appetite, concentration, suicidal ideation, interest, energy, psychomotor retardation or agitation. Scores range from 0-27, higher scores indicating greater depression severity.
Outcome measures
| Measure |
Transcranial Light Therapy
n=18 Participants
Transcranial light therapy penetrates the skin and brain using light energy and, the light energy may activate under-stimulated brain regions.
Transcranial Light Therapy: Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.
|
Sham Transcranial Light Therapy
n=29 Participants
For the sham group, The transcranial light therapy device uses nonpenetrating light emitting diode light energy. The sham controls for which participants improve from the actual transcranial light therapy treatment and which participants improve during the study for reasons other than the therapy
Transcranial Light Therapy: Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.
Sham Transcranial Light Therapy: The same device used for the actual transcranial light therapy is used as the sham device; The device, when set to sham, will mimic the actual transcranial light therapy; however, when set to sham the device does not emit skin and cranium penetrating light emitting diode light energy.
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|---|---|---|
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Quick Inventory of Depressive Symptomatology-Phase 1
|
11.06 score on a scale
Standard Deviation 3.78
|
11.24 score on a scale
Standard Deviation 4.83
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PRIMARY outcome
Timeframe: 6 weeks - Sequential-parallel comparison designPopulation: This group consists of all sham participants that did not respond to Sham in Phase 1 and were re-randomized into Phase 2. Therefore, of the 29 participants in Sham, 5 participants were responders, 4 were not re-randomized.
This is a brief (16-item) clinician-rated inventory of core depressive symptoms such as sleep, depressed mood, appetite, concentration, suicidal ideation, interest, energy, psychomotor retardation or agitation. Scores range from 0-27, higher scores indicating greater depression severity.
Outcome measures
| Measure |
Transcranial Light Therapy
n=11 Participants
Transcranial light therapy penetrates the skin and brain using light energy and, the light energy may activate under-stimulated brain regions.
Transcranial Light Therapy: Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.
|
Sham Transcranial Light Therapy
n=7 Participants
For the sham group, The transcranial light therapy device uses nonpenetrating light emitting diode light energy. The sham controls for which participants improve from the actual transcranial light therapy treatment and which participants improve during the study for reasons other than the therapy
Transcranial Light Therapy: Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.
Sham Transcranial Light Therapy: The same device used for the actual transcranial light therapy is used as the sham device; The device, when set to sham, will mimic the actual transcranial light therapy; however, when set to sham the device does not emit skin and cranium penetrating light emitting diode light energy.
|
|---|---|---|
|
Quick Inventory of Depressive Symptomatology(QIDS)-Phase 2
|
10.45 score on a scale
Standard Deviation 5.751
|
9.14 score on a scale
Standard Deviation 5.551
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SECONDARY outcome
Timeframe: 6 weeks - Sequential-parallel comparison designPopulation: Patients in Sham within the first phase would be re-randomized to either NIR or Sham after completion of the initial 6 weeks. There were two participants in the Sham group who did not have scores for the primary analysis (QIDS), we decided to include them in the secondary analysis (HAMD) as they had scores.
assessment of the patient's depressive symptoms, using a structured interview and defined anchor points. The Hamilton Depression Rating Scale aims to quantify the degree of depression in patients who already have a diagnosis of major depression. Score ranges from 0-52. Higher score indicates greater severity of depression.
Outcome measures
| Measure |
Transcranial Light Therapy
n=18 Participants
Transcranial light therapy penetrates the skin and brain using light energy and, the light energy may activate under-stimulated brain regions.
Transcranial Light Therapy: Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.
|
Sham Transcranial Light Therapy
n=31 Participants
For the sham group, The transcranial light therapy device uses nonpenetrating light emitting diode light energy. The sham controls for which participants improve from the actual transcranial light therapy treatment and which participants improve during the study for reasons other than the therapy
Transcranial Light Therapy: Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.
Sham Transcranial Light Therapy: The same device used for the actual transcranial light therapy is used as the sham device; The device, when set to sham, will mimic the actual transcranial light therapy; however, when set to sham the device does not emit skin and cranium penetrating light emitting diode light energy.
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|---|---|---|
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Hamilton Depression Rating Scale - 17 Items(Phase 1)
|
16.28 score on a scale
Standard Deviation 5.345
|
15.81 score on a scale
Standard Deviation 6.685
|
SECONDARY outcome
Timeframe: 6 weeks - Sequential-parallel comparison designPopulation: This group consists of all sham participants that did not respond to Sham in Phase 1 and were re-randomized into Phase 2. Therefore, of the 29 participants in Sham, 5 participants were responders, 4 were not re-randomized. 1 participant was not assessed with HAMD but was assessed with primary measure (QIDS), as such there are 10 in TLT group.
assessment of the patient's depressive symptoms, using a structured interview and defined anchor points. The Hamilton Depression Rating Scale aims to quantify the degree of depression in patients who already have a diagnosis of major depression. Score ranges from 0-52. Higher score indicates greater severity of depression.
Outcome measures
| Measure |
Transcranial Light Therapy
n=10 Participants
Transcranial light therapy penetrates the skin and brain using light energy and, the light energy may activate under-stimulated brain regions.
Transcranial Light Therapy: Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.
|
Sham Transcranial Light Therapy
n=7 Participants
For the sham group, The transcranial light therapy device uses nonpenetrating light emitting diode light energy. The sham controls for which participants improve from the actual transcranial light therapy treatment and which participants improve during the study for reasons other than the therapy
Transcranial Light Therapy: Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.
Sham Transcranial Light Therapy: The same device used for the actual transcranial light therapy is used as the sham device; The device, when set to sham, will mimic the actual transcranial light therapy; however, when set to sham the device does not emit skin and cranium penetrating light emitting diode light energy.
|
|---|---|---|
|
Hamilton Depression Rating Scale - 17 Items(Phase 2)
|
13.50 score on a scale
Standard Deviation 6.151
|
14.14 score on a scale
Standard Deviation 6.768
|
Adverse Events
Transcranial Light Therapy
Sham Transcranial Light Therapy
Serious adverse events
| Measure |
Transcranial Light Therapy
n=31 participants at risk
Transcranial light therapy penetrates the skin and brain using light energy and, the light energy may activate under-stimulated brain regions.
Transcranial Light Therapy: Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.
|
Sham Transcranial Light Therapy
n=31 participants at risk
For the sham group, The transcranial light therapy device uses nonpenetrating light emitting diode light energy. The sham controls for which participants improve from the actual transcranial light therapy treatment and which participants improve during the study for reasons other than the therapy
Transcranial Light Therapy: Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.
Sham Transcranial Light Therapy: The same device used for the actual transcranial light therapy is used as the sham device; The device, when set to sham, will mimic the actual transcranial light therapy; however, when set to sham the device does not emit skin and cranium penetrating light emitting diode light energy.
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|---|---|---|
|
Psychiatric disorders
Aborted Suicide Attempt
|
0.00%
0/31 • Timeframe of collection was during participation in the two phases of the study and follow up visit 1 week after completion. Therefore, the total timeframe of assessment is 13 weeks.
Our participants flow differs for the following reasons: Per the SPCD design, subjects within the Sham group in Phase 1 are re-randomized in Phase 2 to receive either Sham or TLT treatment. Therefore, TLT group accounts for participants receiving TLT in the first phase as well as those re-randomized to TLT in their second phase. Participants in Sham account for all subjects randomized to sham in Phase 1, regardless of whether they were re-randomized to Sham or TLT in Phase 2.
|
3.2%
1/31 • Number of events 1 • Timeframe of collection was during participation in the two phases of the study and follow up visit 1 week after completion. Therefore, the total timeframe of assessment is 13 weeks.
Our participants flow differs for the following reasons: Per the SPCD design, subjects within the Sham group in Phase 1 are re-randomized in Phase 2 to receive either Sham or TLT treatment. Therefore, TLT group accounts for participants receiving TLT in the first phase as well as those re-randomized to TLT in their second phase. Participants in Sham account for all subjects randomized to sham in Phase 1, regardless of whether they were re-randomized to Sham or TLT in Phase 2.
|
Other adverse events
| Measure |
Transcranial Light Therapy
n=31 participants at risk
Transcranial light therapy penetrates the skin and brain using light energy and, the light energy may activate under-stimulated brain regions.
Transcranial Light Therapy: Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.
|
Sham Transcranial Light Therapy
n=31 participants at risk
For the sham group, The transcranial light therapy device uses nonpenetrating light emitting diode light energy. The sham controls for which participants improve from the actual transcranial light therapy treatment and which participants improve during the study for reasons other than the therapy
Transcranial Light Therapy: Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.
Sham Transcranial Light Therapy: The same device used for the actual transcranial light therapy is used as the sham device; The device, when set to sham, will mimic the actual transcranial light therapy; however, when set to sham the device does not emit skin and cranium penetrating light emitting diode light energy.
|
|---|---|---|
|
General disorders
Headache
|
29.0%
9/31 • Timeframe of collection was during participation in the two phases of the study and follow up visit 1 week after completion. Therefore, the total timeframe of assessment is 13 weeks.
Our participants flow differs for the following reasons: Per the SPCD design, subjects within the Sham group in Phase 1 are re-randomized in Phase 2 to receive either Sham or TLT treatment. Therefore, TLT group accounts for participants receiving TLT in the first phase as well as those re-randomized to TLT in their second phase. Participants in Sham account for all subjects randomized to sham in Phase 1, regardless of whether they were re-randomized to Sham or TLT in Phase 2.
|
22.6%
7/31 • Timeframe of collection was during participation in the two phases of the study and follow up visit 1 week after completion. Therefore, the total timeframe of assessment is 13 weeks.
Our participants flow differs for the following reasons: Per the SPCD design, subjects within the Sham group in Phase 1 are re-randomized in Phase 2 to receive either Sham or TLT treatment. Therefore, TLT group accounts for participants receiving TLT in the first phase as well as those re-randomized to TLT in their second phase. Participants in Sham account for all subjects randomized to sham in Phase 1, regardless of whether they were re-randomized to Sham or TLT in Phase 2.
|
|
General disorders
Worsening of Pre-Existing Condition
|
9.7%
3/31 • Timeframe of collection was during participation in the two phases of the study and follow up visit 1 week after completion. Therefore, the total timeframe of assessment is 13 weeks.
Our participants flow differs for the following reasons: Per the SPCD design, subjects within the Sham group in Phase 1 are re-randomized in Phase 2 to receive either Sham or TLT treatment. Therefore, TLT group accounts for participants receiving TLT in the first phase as well as those re-randomized to TLT in their second phase. Participants in Sham account for all subjects randomized to sham in Phase 1, regardless of whether they were re-randomized to Sham or TLT in Phase 2.
|
9.7%
3/31 • Timeframe of collection was during participation in the two phases of the study and follow up visit 1 week after completion. Therefore, the total timeframe of assessment is 13 weeks.
Our participants flow differs for the following reasons: Per the SPCD design, subjects within the Sham group in Phase 1 are re-randomized in Phase 2 to receive either Sham or TLT treatment. Therefore, TLT group accounts for participants receiving TLT in the first phase as well as those re-randomized to TLT in their second phase. Participants in Sham account for all subjects randomized to sham in Phase 1, regardless of whether they were re-randomized to Sham or TLT in Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
6.5%
2/31 • Timeframe of collection was during participation in the two phases of the study and follow up visit 1 week after completion. Therefore, the total timeframe of assessment is 13 weeks.
Our participants flow differs for the following reasons: Per the SPCD design, subjects within the Sham group in Phase 1 are re-randomized in Phase 2 to receive either Sham or TLT treatment. Therefore, TLT group accounts for participants receiving TLT in the first phase as well as those re-randomized to TLT in their second phase. Participants in Sham account for all subjects randomized to sham in Phase 1, regardless of whether they were re-randomized to Sham or TLT in Phase 2.
|
19.4%
6/31 • Timeframe of collection was during participation in the two phases of the study and follow up visit 1 week after completion. Therefore, the total timeframe of assessment is 13 weeks.
Our participants flow differs for the following reasons: Per the SPCD design, subjects within the Sham group in Phase 1 are re-randomized in Phase 2 to receive either Sham or TLT treatment. Therefore, TLT group accounts for participants receiving TLT in the first phase as well as those re-randomized to TLT in their second phase. Participants in Sham account for all subjects randomized to sham in Phase 1, regardless of whether they were re-randomized to Sham or TLT in Phase 2.
|
|
Psychiatric disorders
Insomnia
|
16.1%
5/31 • Timeframe of collection was during participation in the two phases of the study and follow up visit 1 week after completion. Therefore, the total timeframe of assessment is 13 weeks.
Our participants flow differs for the following reasons: Per the SPCD design, subjects within the Sham group in Phase 1 are re-randomized in Phase 2 to receive either Sham or TLT treatment. Therefore, TLT group accounts for participants receiving TLT in the first phase as well as those re-randomized to TLT in their second phase. Participants in Sham account for all subjects randomized to sham in Phase 1, regardless of whether they were re-randomized to Sham or TLT in Phase 2.
|
12.9%
4/31 • Timeframe of collection was during participation in the two phases of the study and follow up visit 1 week after completion. Therefore, the total timeframe of assessment is 13 weeks.
Our participants flow differs for the following reasons: Per the SPCD design, subjects within the Sham group in Phase 1 are re-randomized in Phase 2 to receive either Sham or TLT treatment. Therefore, TLT group accounts for participants receiving TLT in the first phase as well as those re-randomized to TLT in their second phase. Participants in Sham account for all subjects randomized to sham in Phase 1, regardless of whether they were re-randomized to Sham or TLT in Phase 2.
|
|
Psychiatric disorders
Irritability With and Without Impulsivity
|
3.2%
1/31 • Timeframe of collection was during participation in the two phases of the study and follow up visit 1 week after completion. Therefore, the total timeframe of assessment is 13 weeks.
Our participants flow differs for the following reasons: Per the SPCD design, subjects within the Sham group in Phase 1 are re-randomized in Phase 2 to receive either Sham or TLT treatment. Therefore, TLT group accounts for participants receiving TLT in the first phase as well as those re-randomized to TLT in their second phase. Participants in Sham account for all subjects randomized to sham in Phase 1, regardless of whether they were re-randomized to Sham or TLT in Phase 2.
|
12.9%
4/31 • Timeframe of collection was during participation in the two phases of the study and follow up visit 1 week after completion. Therefore, the total timeframe of assessment is 13 weeks.
Our participants flow differs for the following reasons: Per the SPCD design, subjects within the Sham group in Phase 1 are re-randomized in Phase 2 to receive either Sham or TLT treatment. Therefore, TLT group accounts for participants receiving TLT in the first phase as well as those re-randomized to TLT in their second phase. Participants in Sham account for all subjects randomized to sham in Phase 1, regardless of whether they were re-randomized to Sham or TLT in Phase 2.
|
|
Psychiatric disorders
Panic Attack
|
3.2%
1/31 • Timeframe of collection was during participation in the two phases of the study and follow up visit 1 week after completion. Therefore, the total timeframe of assessment is 13 weeks.
Our participants flow differs for the following reasons: Per the SPCD design, subjects within the Sham group in Phase 1 are re-randomized in Phase 2 to receive either Sham or TLT treatment. Therefore, TLT group accounts for participants receiving TLT in the first phase as well as those re-randomized to TLT in their second phase. Participants in Sham account for all subjects randomized to sham in Phase 1, regardless of whether they were re-randomized to Sham or TLT in Phase 2.
|
9.7%
3/31 • Timeframe of collection was during participation in the two phases of the study and follow up visit 1 week after completion. Therefore, the total timeframe of assessment is 13 weeks.
Our participants flow differs for the following reasons: Per the SPCD design, subjects within the Sham group in Phase 1 are re-randomized in Phase 2 to receive either Sham or TLT treatment. Therefore, TLT group accounts for participants receiving TLT in the first phase as well as those re-randomized to TLT in their second phase. Participants in Sham account for all subjects randomized to sham in Phase 1, regardless of whether they were re-randomized to Sham or TLT in Phase 2.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/31 • Timeframe of collection was during participation in the two phases of the study and follow up visit 1 week after completion. Therefore, the total timeframe of assessment is 13 weeks.
Our participants flow differs for the following reasons: Per the SPCD design, subjects within the Sham group in Phase 1 are re-randomized in Phase 2 to receive either Sham or TLT treatment. Therefore, TLT group accounts for participants receiving TLT in the first phase as well as those re-randomized to TLT in their second phase. Participants in Sham account for all subjects randomized to sham in Phase 1, regardless of whether they were re-randomized to Sham or TLT in Phase 2.
|
6.5%
2/31 • Timeframe of collection was during participation in the two phases of the study and follow up visit 1 week after completion. Therefore, the total timeframe of assessment is 13 weeks.
Our participants flow differs for the following reasons: Per the SPCD design, subjects within the Sham group in Phase 1 are re-randomized in Phase 2 to receive either Sham or TLT treatment. Therefore, TLT group accounts for participants receiving TLT in the first phase as well as those re-randomized to TLT in their second phase. Participants in Sham account for all subjects randomized to sham in Phase 1, regardless of whether they were re-randomized to Sham or TLT in Phase 2.
|
|
General disorders
Pressure on Forehead/Head
|
12.9%
4/31 • Timeframe of collection was during participation in the two phases of the study and follow up visit 1 week after completion. Therefore, the total timeframe of assessment is 13 weeks.
Our participants flow differs for the following reasons: Per the SPCD design, subjects within the Sham group in Phase 1 are re-randomized in Phase 2 to receive either Sham or TLT treatment. Therefore, TLT group accounts for participants receiving TLT in the first phase as well as those re-randomized to TLT in their second phase. Participants in Sham account for all subjects randomized to sham in Phase 1, regardless of whether they were re-randomized to Sham or TLT in Phase 2.
|
6.5%
2/31 • Timeframe of collection was during participation in the two phases of the study and follow up visit 1 week after completion. Therefore, the total timeframe of assessment is 13 weeks.
Our participants flow differs for the following reasons: Per the SPCD design, subjects within the Sham group in Phase 1 are re-randomized in Phase 2 to receive either Sham or TLT treatment. Therefore, TLT group accounts for participants receiving TLT in the first phase as well as those re-randomized to TLT in their second phase. Participants in Sham account for all subjects randomized to sham in Phase 1, regardless of whether they were re-randomized to Sham or TLT in Phase 2.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place