Trial Outcomes & Findings for Fronto-temporal tDCS Mproves Fluency & Empathy in ASD Kids (NCT NCT02004236)
NCT ID: NCT02004236
Last Updated: 2024-09-19
Results Overview
Goal: Improve in verbal fluency in ASD children between 5 and 12 years. We use D-KEFS (Delis-Kaplan Executive Function System Delis Kaplan Sorting Test), Verbal Fluency Subtest - Category Condition. Description: The verbal fluency Category test evaluates fluent productivity in the verbal domain by asking participants to generate exemplars belonging to the category animals, and subsequently, boys´ names. Participants were given 60 s to do it. Values: Category scores were based on the average number of items generated in the two categories (animals and boys´names) during 60 s. Time Frame: Baseline (Before treatment) and 1 day Post-treatment (after completing 3 months of intensive speech therapy during tRNS sessions)
COMPLETED
NA
225 participants
During 3 months of intensive speech therapy during tRNS sessions
2024-09-19
Participant Flow
Participant milestones
| Measure |
tRNS Over Fronto-temporal Cortex
This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex
|
tRNS Over Fusiform Temporal Cortex
This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex
|
tRNS With Sham
This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham
|
|---|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
75
|
|
Overall Study
COMPLETED
|
75
|
75
|
59
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
16
|
Reasons for withdrawal
| Measure |
tRNS Over Fronto-temporal Cortex
This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex
|
tRNS Over Fusiform Temporal Cortex
This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex
|
tRNS With Sham
This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
16
|
Baseline Characteristics
Fronto-temporal tDCS Mproves Fluency & Empathy in ASD Kids
Baseline characteristics by cohort
| Measure |
tRNS Fronto-temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex
|
tRNS Over Fusiform Temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex
|
tRNS With Sham
n=59 Participants
This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham
|
Total
n=209 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
7.5 years
STANDARD_DEVIATION 1.98 • n=5 Participants
|
6.9 years
STANDARD_DEVIATION 2.1 • n=7 Participants
|
7.2 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
7.2 years
STANDARD_DEVIATION 2.12 • n=4 Participants
|
|
Age, Categorical
<=18 years
|
75 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
209 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Customized
4-6 years
|
5.1 years
STANDARD_DEVIATION 0.80 • n=5 Participants
|
4.8 years
STANDARD_DEVIATION 1.17 • n=7 Participants
|
5.3 years
STANDARD_DEVIATION 0.75 • n=5 Participants
|
5.06 years
STANDARD_DEVIATION 0.91 • n=4 Participants
|
|
Age, Customized
7-9 years
|
7.2 years
STANDARD_DEVIATION 0.9 • n=5 Participants
|
8.4 years
STANDARD_DEVIATION 0.73 • n=7 Participants
|
7.8 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
7.8 years
STANDARD_DEVIATION 0.91 • n=4 Participants
|
|
Age, Customized
10-12 years
|
11.2 years
STANDARD_DEVIATION 0.48 • n=5 Participants
|
10.1 years
STANDARD_DEVIATION 0.69 • n=7 Participants
|
10.8 years
STANDARD_DEVIATION 0.88 • n=5 Participants
|
10.7 years
STANDARD_DEVIATION 0.68 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
209 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
75 participants
n=5 Participants
|
75 participants
n=7 Participants
|
59 participants
n=5 Participants
|
209 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: During 3 months of intensive speech therapy during tRNS sessionsPopulation: Time frame: Baseline Before treatment and after completing 3 months of intensive speech therapy during tRNS sessions.
Goal: Improve in verbal fluency in ASD children between 5 and 12 years. We use D-KEFS (Delis-Kaplan Executive Function System Delis Kaplan Sorting Test), Verbal Fluency Subtest - Category Condition. Description: The verbal fluency Category test evaluates fluent productivity in the verbal domain by asking participants to generate exemplars belonging to the category animals, and subsequently, boys´ names. Participants were given 60 s to do it. Values: Category scores were based on the average number of items generated in the two categories (animals and boys´names) during 60 s. Time Frame: Baseline (Before treatment) and 1 day Post-treatment (after completing 3 months of intensive speech therapy during tRNS sessions)
Outcome measures
| Measure |
tRNS Fronto-temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex
|
tRNS Over Fusiform Temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex
|
tRNS With Sham
n=59 Participants
This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham
|
|---|---|---|---|
|
Verbal Fluency
before tRNS
|
9.3 units on a scale
Standard Deviation 1.3
|
10.5 units on a scale
Standard Deviation 1.6
|
9.9 units on a scale
Standard Deviation 1.1
|
|
Verbal Fluency
after tRNS
|
8.3 units on a scale
Standard Deviation 1.2
|
10.4 units on a scale
Standard Deviation 1.1
|
10 units on a scale
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: During 3 months of intensive speech therapy during tRNS sessionsPopulation: Time frame: Baseline Before treatment and after completing 3 months of intensive speech therapy during tRNS sessions.
Goal: Evaluate emphaty with CARS scale in autism spectrum disorder children between 5 and 12 years after tRNS sessions. CARS (Childhood Autism Rating Scale) by Shopler \& Reichler (1971) in Spanish version EVAI (Escala de Valoración de Autismo Infantil) by Leal-Soto, F.; Aguirre, L.P. y Williams, E.E. Description: 15 items in the scale that evaluate: Relating to people, Imitative Behavior, Emotional Response, Body Use, Object Use, Adaptation to Change, Visual Response, Listening Response, Perceptive Response, Fear or Anxiety, Verbal Communication, Non-Verbal Communication, Activity level, Level and consistency of Intellective Relations and General Impressions. Values: The CARS scores range from 15 to 60, with lower scores indicating better outcome. It classifies the child as not autistic (below 30), moderately autistic (30-36.5) or severely autistic (above 36.5)
Outcome measures
| Measure |
tRNS Fronto-temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex
|
tRNS Over Fusiform Temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex
|
tRNS With Sham
n=59 Participants
This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham
|
|---|---|---|---|
|
Sociability
before tRNS
|
30.6 units on a scale
Standard Deviation 1.9
|
32.1 units on a scale
Standard Deviation 2.2
|
31.8 units on a scale
Standard Deviation 3.4
|
|
Sociability
after tRNS
|
19.4 units on a scale
Standard Deviation 2.1
|
20.2 units on a scale
Standard Deviation 1.8
|
30.1 units on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: During 3 months of intensive speech therapy during tRNS sessionsThe purpose of the present study was to determine if the theta/beta ratio, and theta and beta separately, correlate with behavioral parameters, and if these measures discriminate between children a with Autism Spectrum disorder (ASD) and normal gender- and age-matched controls before and after tRNS intervention in ASD children between 5 and 12 years old.
Outcome measures
| Measure |
tRNS Fronto-temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex
|
tRNS Over Fusiform Temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex
|
tRNS With Sham
n=59 Participants
This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham
|
|---|---|---|---|
|
Ratio Theta/Beta Before tDCS
|
25 Ratio theta/beta before tRNS
Standard Deviation 0.88
|
30 Ratio theta/beta before tRNS
Standard Deviation 1.1
|
26 Ratio theta/beta before tRNS
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: During 3 months of intensive speech therapy during tRNS sessionsThe purpose of the present study was to determine if the theta/beta ratio, and theta and beta separately, correlate with behavioral parameters, and if these measures discriminate between children a with Autism Spectrum disorder (ASD) and normal gender- and age-matched controls before and after tRNS intervention in ASD children between 5 and 12 years old.
Outcome measures
| Measure |
tRNS Fronto-temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex
|
tRNS Over Fusiform Temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex
|
tRNS With Sham
n=59 Participants
This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham
|
|---|---|---|---|
|
Theta Amplitude in T5 Before tDCS
|
3.2 MicroVolts
Standard Deviation 0.3
|
2.7 MicroVolts
Standard Deviation 0.11
|
3.5 MicroVolts
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: During 3 months of intensive speech therapy during tDCS sessionsThe purpose of the present study was to determine if the theta/beta ratio, and theta and beta separately, correlate with behavioral parameters, and if these measures discriminate between children a with Autism Spectrum disorder (ASD) and normal gender- and age-matched controls before and after tDCS intervention in ASD children between 5 and 12 years old.
Outcome measures
| Measure |
tRNS Fronto-temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex
|
tRNS Over Fusiform Temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex
|
tRNS With Sham
n=59 Participants
This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham
|
|---|---|---|---|
|
Ratio Theta/Beta After tDCS
|
12 Ratio theta/beta after tRNS
Standard Deviation 1.1
|
14 Ratio theta/beta after tRNS
Standard Deviation 0.52
|
25 Ratio theta/beta after tRNS
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: During 3 months of intensive speech therapy during tRNS sessionsEvaluate QEEG (brainwave changes in frequency bandfs and amplitude) after tRNS intervention in ASD children between 5 and 12 years old
Outcome measures
| Measure |
tRNS Fronto-temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex
|
tRNS Over Fusiform Temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex
|
tRNS With Sham
n=59 Participants
This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham
|
|---|---|---|---|
|
Theta Amplitude in T5 After tDCS
|
2.2 MicroVolts
Standard Deviation 0.41
|
1.5 MicroVolts
Standard Deviation 0.36
|
3.3 MicroVolts
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: During 3 months of intensive speech therapy during tRNS sessionsERP \& Behaviour changes in ASD children after tDCS
Outcome measures
| Measure |
tRNS Fronto-temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex
|
tRNS Over Fusiform Temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex
|
tRNS With Sham
n=59 Participants
This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham
|
|---|---|---|---|
|
Reaction Time in ECPT Before tDCS
|
756 Milliseconds
Standard Deviation 23.5
|
698 Milliseconds
Standard Deviation 34.2
|
722 Milliseconds
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: During 3 months of intensive speech therapy during tRNS sessionsERP and behaviour changes in ASD children before tDCS
Outcome measures
| Measure |
tRNS Fronto-temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex
|
tRNS Over Fusiform Temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex
|
tRNS With Sham
n=59 Participants
This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham
|
|---|---|---|---|
|
Omission Errors Before tDCS
|
85 number of errors during ECPT task
Standard Deviation 5.2
|
91 number of errors during ECPT task
Standard Deviation 3.2
|
88 number of errors during ECPT task
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: During 3 months of intensive speech therapy during tDCS sessionsERP and Behaviour changes in ASD children before tDCS
Outcome measures
| Measure |
tRNS Fronto-temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex
|
tRNS Over Fusiform Temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex
|
tRNS With Sham
n=59 Participants
This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham
|
|---|---|---|---|
|
Commission Errors Before tDCS
|
6 number of omission errors VCPT task
Standard Deviation 0.2
|
8 number of omission errors VCPT task
Standard Deviation 1.1
|
19 number of omission errors VCPT task
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: During 3 months of intensive speech therapy during tRNS sessionsERP and behaviour Changes in ASD children before tDCS
Outcome measures
| Measure |
tRNS Fronto-temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex
|
tRNS Over Fusiform Temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex
|
tRNS With Sham
n=59 Participants
This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham
|
|---|---|---|---|
|
P3b Wave Amplitude Before tDCS
|
0.5 MicroVolts or Amplitude P3b wave
Standard Deviation 0.12
|
0.7 MicroVolts or Amplitude P3b wave
Standard Deviation 0.4
|
0.3 MicroVolts or Amplitude P3b wave
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: During 3 months of intensive speech therapy during tDCS sessionsERP and behaviour Changes in ASD children after tDCS
Outcome measures
| Measure |
tRNS Fronto-temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex
|
tRNS Over Fusiform Temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex
|
tRNS With Sham
n=59 Participants
This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham
|
|---|---|---|---|
|
Reaction Time After tDCS
|
690 Reaction Time measuring in Milliseconds
Standard Deviation 10.4
|
556 Reaction Time measuring in Milliseconds
Standard Deviation 7.4
|
714 Reaction Time measuring in Milliseconds
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: During 3 months of intensive speech therapy during tDCS sessionsERP and behaviour Changes in ASD children after tDCS
Outcome measures
| Measure |
tRNS Fronto-temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex
|
tRNS Over Fusiform Temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex
|
tRNS With Sham
n=75 Participants
This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham
|
|---|---|---|---|
|
Omissions Errors After tDCS
|
68 number of omission errors in VCPT task
Standard Deviation 2.3
|
57 number of omission errors in VCPT task
Standard Deviation 4.7
|
20 number of omission errors in VCPT task
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: During 3 months of intensive speech therapy during tDCS sessionsERP and behaviour Changes in ASD children after tDCS
Outcome measures
| Measure |
tRNS Fronto-temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex
|
tRNS Over Fusiform Temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex
|
tRNS With Sham
n=59 Participants
This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham
|
|---|---|---|---|
|
Commission Errors After tDCS
|
6 number of commission errors in VCPT task
Standard Deviation 0.2
|
8 number of commission errors in VCPT task
Standard Deviation 1.1
|
19 number of commission errors in VCPT task
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: During 3 months of intensive speech therapy during tDCS sessionsERP and behaviour Changes in ASD children after tDCS
Outcome measures
| Measure |
tRNS Fronto-temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex
|
tRNS Over Fusiform Temporal Cortex
n=75 Participants
This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex
|
tRNS With Sham
n=59 Participants
This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham
|
|---|---|---|---|
|
P3b Wave Amplitude After tDCS
|
2.1 MicroVolts or Amplitude P3b wave
Standard Deviation 0.25
|
1.8 MicroVolts or Amplitude P3b wave
Standard Deviation 0.65
|
0.4 MicroVolts or Amplitude P3b wave
Standard Deviation 0.32
|
Adverse Events
tRNS Fronto-temporal Cortex
tRNS Over Fusiform Temporal Cortex
tRNS With Sham
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
tRNS Fronto-temporal Cortex
n=75 participants at risk
This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex
|
tRNS Over Fusiform Temporal Cortex
n=75 participants at risk
This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex
|
tRNS With Sham
n=59 participants at risk
This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
1.3%
1/75 • Number of events 1
|
2.7%
2/75 • Number of events 2
|
0.00%
0/59
|
Additional Information
Moises Domingo president of Brainmech Foundation
BrainMech Foundation
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60