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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

225 participants

Primary outcome timeframe

During 3 months of intensive speech therapy during tRNS sessions

Results posted on

2024-09-19

Participant Flow

Participant milestones

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

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

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 sessions

Population: 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

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 sessions

Population: 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

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 sessions

The 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

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 sessions

The 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

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 sessions

The 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

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 sessions

Evaluate QEEG (brainwave changes in frequency bandfs and amplitude) after tRNS intervention in ASD children between 5 and 12 years old

Outcome measures

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 sessions

ERP \& Behaviour changes in ASD children after tDCS

Outcome measures

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 sessions

ERP and behaviour changes in ASD children before tDCS

Outcome measures

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 sessions

ERP and Behaviour changes in ASD children before tDCS

Outcome measures

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 sessions

ERP and behaviour Changes in ASD children before tDCS

Outcome measures

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 sessions

ERP and behaviour Changes in ASD children after tDCS

Outcome measures

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 sessions

ERP and behaviour Changes in ASD children after tDCS

Outcome measures

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 sessions

ERP and behaviour Changes in ASD children after tDCS

Outcome measures

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 sessions

ERP and behaviour Changes in ASD children after tDCS

Outcome measures

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

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

tRNS Over Fusiform Temporal Cortex

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

tRNS With Sham

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Phone: +441615312645

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60