Back to resultsThe Efficacy of "Mindtesion"is Measuring Attentional and the Startle Response Dysregulation in Children and Adolescents Suffering From Attention Deficit Disorder: With and Without Medication.
Primary Purpose
Attention Deficit Disorder With Hyperactivity
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
MT1 Device
Sponsored by
About this trial
This is an interventional diagnostic trial for Attention Deficit Disorder With Hyperactivity focused on measuring ADHD, Attention
Eligibility Criteria
Inclusion Criteria: (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. Exclusion Criteria: (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.
Sites / Locations
- ADHD clinic, Dan Petach-Tiqva, Geha MHC, ClalitRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MPH / AMPH Treatment
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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
ADHD severity
ADHD-RS-IV questionnaire ADHD-RS-IV questionnaire
Impulsive dysregulation
Clinical Global Impression (CGI): Clinical Global Impression - Severity and Clinical Global Impression - Improvement (CGI-S, CGI-I, respectively)
Secondary Outcome Measures
CBCL
A questionnaire filled by the parents to describe their children's behavioral and emotional problems, version CBCL/4 to 18
Changes in treatment
Tolerability, switching rate, changes in formulation is examined using information from electronic medical records three clinical follow-up visits.
Full Information
NCT ID
NCT05753969
First Posted
February 23, 2023
Last Updated
February 23, 2023
Sponsor
Geha Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT05753969
Brief Title
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.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Geha Mental Health Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Double blind, placebo-controlled clinical study designed to evaluate Mindtension device and Protocol as a diagnostic tool in children diagnosed with ADHD
Detailed Description
Mindtension device measures the orbicularis muscle response to auditory stimuli, the device is backed up by an algorithm that calculate the several parameters of startle reflex such as the Paired-pulse inhibition (PPI), Habituation, and startle related indices.
Data collected by the device is used to evaluate the subject levels of attention, Hyperarousal and Impulsivity, by means of physiological EMG signals of the startle response.
Evaluating baseline differences in these parameters between ADHD and age matched healthy controls, and the possible improvement after psychostimulant medications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
ADHD, Attention
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MPH / AMPH Treatment
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
MT1 Device
Other Intervention Name(s)
Mindtension Attention Algorithm
Intervention Description
Pre-and post-evaluation in MT1 device following stimulant treatment or placebo control
Primary Outcome Measure Information:
Title
Mindtension EMG values
Description
startle reflex indices such as the Paired-pulse inhibition (PPI), Habituation, and startle response amplitude, eye-blink probability, amplitude coefficients, inter-trial variability
Time Frame
baseline and 1 hour post treatment
Title
ADHD severity
Description
ADHD-RS-IV questionnaire ADHD-RS-IV questionnaire
Time Frame
Baseline
Title
Impulsive dysregulation
Description
Clinical Global Impression (CGI): Clinical Global Impression - Severity and Clinical Global Impression - Improvement (CGI-S, CGI-I, respectively)
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
CBCL
Description
A questionnaire filled by the parents to describe their children's behavioral and emotional problems, version CBCL/4 to 18
Time Frame
Baseline
Title
Changes in treatment
Description
Tolerability, switching rate, changes in formulation is examined using information from electronic medical records three clinical follow-up visits.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
(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.
Exclusion Criteria:
(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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iris Manor, MD
Phone
+97239728600
Email
IManor@clalit.org.il
Facility Information:
Facility Name
ADHD clinic, Dan Petach-Tiqva, Geha MHC, Clalit
City
Petah Tikwah
ZIP/Postal Code
4954040
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iris Manor, MD
Phone
+972-3-972-8600
Email
IManor@clalit.org.il
12. IPD Sharing Statement
Learn more about this trial
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.
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