The Efficacy of "Mindtesion"is Measuring Attentional and the Startle Response Dysregulation in Children and Adolescents Suffering From Attention Deficit Disorder: With and Without Medication.
1 other identifier
interventional
200
1 country
1
Brief Summary
Double blind, placebo-controlled clinical study designed to evaluate Mindtension device and Protocol as a diagnostic tool in children diagnosed with ADHD
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 23, 2021
CompletedFirst Submitted
Initial submission to the registry
February 23, 2023
CompletedFirst Posted
Study publicly available on registry
March 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2024
CompletedMarch 3, 2023
February 1, 2023
2.9 years
February 23, 2023
February 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Mindtension EMG values
startle reflex indices such as the Paired-pulse inhibition (PPI), Habituation, and startle response amplitude, eye-blink probability, amplitude coefficients, inter-trial variability
baseline and 1 hour post treatment
ADHD severity
ADHD-RS-IV questionnaire ADHD-RS-IV questionnaire
Baseline
Impulsive dysregulation
Clinical Global Impression (CGI): Clinical Global Impression - Severity and Clinical Global Impression - Improvement (CGI-S, CGI-I, respectively)
Baseline
Secondary Outcomes (2)
CBCL
Baseline
Changes in treatment
Baseline
Study Arms (2)
MPH / AMPH Treatment
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Pre-and post-evaluation in MT1 device following stimulant treatment or placebo control
Eligibility Criteria
You may qualify if:
- (i) Children with ADHD according to DSM-5 criteria in a semi-structured interview by a senior psychiatrist.
- (ii) Reaching 85 percent score on the ADHD-RS scale. (iii) Treated with a stimulant in the perceived optimal dosage.
You may not qualify if:
- (i) autism spectrum disorder. (ii) chronic neurological disorders and chronic medical conditions (e.g., diabetes).
- (iii) schizophrenia spectrum and other psychotic disorders. (iv) substance abuse (drugs or alcohol). (v) depression. (vi) hearing loss. (vii) lack of cooperation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ADHD clinic, Dan Petach-Tiqva, Geha MHC, Clalit
Petah Tikva, 4954040, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of ADHD clinic, Dan Petach-Tiqva, Geha MHC, Clalit
Study Record Dates
First Submitted
February 23, 2023
First Posted
March 3, 2023
Study Start
February 23, 2021
Primary Completion
December 31, 2023
Study Completion
February 28, 2024
Last Updated
March 3, 2023
Record last verified: 2023-02