Attention Deficit Disorder With HyperactivityNCT05753969
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.
A study testing MT1 Device in people with Attention Deficit Disorder With Hyperactivity, run by Geha Mental Health Center at 1 site in Israel.
Trial summary
Double blind, placebo-controlled clinical study designed to evaluate Mindtension device and Protocol as a diagnostic tool in children diagnosed with ADHD Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- MT1 Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 23 Feb 2021to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children with ADHD according to DSM-5 criteria in a semi-structured interview by a senior psychiatrist.
- Reaching 85 percent score on the ADHD-RS scale. (iii) Treated with a stimulant in the perceived optimal dosage.
Who cannot join
- autism spectrum disorder. (ii) chronic neurological disorders and chronic medical conditions (e.g., diabetes).
- schizophrenia spectrum and other psychotic disorders. (iv) substance abuse (drugs or alcohol). (v) depression. (vi) hearing loss. (vii) lack of cooperation.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
ADHD clinic, Dan Petach-Tiqva, Geha MHC, Clalit
Petah Tikva, 4954040
Iris Manor, MD, +972-3-972-8600, IManor@clalit.org.il
About this study
Double blind, placebo-controlled clinical study designed to evaluate Mindtension device and Protocol as a diagnostic tool in children diagnosed with ADHD
Read the 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.
- Being tested
- MT1 Device
- Keywords
- ADHD, Attention
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT1 DeviceDevice
Also called Mindtension Attention Algorithm
Pre-and post-evaluation in MT1 device following stimulant treatment or placebo control
| Study group | Role | What they receive |
|---|---|---|
| MPH / AMPH Treatment | Experimental | Not described Receives: Device: MT1 Device |
| Placebo | Placebo comparator | Not described Receives: Device: MT1 Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and 1 hour post treatment
ADHD severity
ADHD-RS-IV questionnaire ADHD-RS-IV questionnaire
Measured: Baseline
Impulsive dysregulation
Clinical Global Impression (CGI): Clinical Global Impression - Severity and Clinical Global Impression - Improvement (CGI-S, CGI-I, respectively)
Measured: Baseline
Secondary outcomes (2)
CBCL
A questionnaire filled by the parents to describe their children's behavioral and emotional problems, version CBCL/4 to 18
Measured: Baseline
Changes in treatment
Tolerability, switching rate, changes in formulation is examined using information from electronic medical records three clinical follow-up visits.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start23 Feb 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geha Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iris Manor, Geha Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753969
- Sponsor's protocol ID
- 01-20-GEH
- Status last verified
- Feb 2023
- First submitted
- 23 Feb 2023
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05753969
- Acronym / sponsor ID
- 01-20-GEH
- Keywords
- ADHD, Attention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Geha Mental Health CenterUniversity, hospital or other
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 3 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPH / AMPH Treatment | Experimental | Device: MT1 Device |
| Placebo | Placebo comparator | Device: MT1 Device |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children with ADHD according to DSM-5 criteria in a semi-structured interview by a senior psychiatrist.
- Reaching 85 percent score on the ADHD-RS scale. (iii) Treated with a stimulant in the perceived optimal dosage.
Key exclusion criteria (2 listed)
- autism spectrum disorder. (ii) chronic neurological disorders and chronic medical conditions (e.g., diabetes).
- schizophrenia spectrum and other psychotic disorders. (iv) substance abuse (drugs or alcohol). (v) depression. (vi) hearing loss. (vii) lack of cooperation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT1 DeviceAlso: Mindtension Attention AlgorithmPre-and post-evaluation in MT1 device following stimulant treatment or placebo control | Device | MPH / AMPH Treatment, Placebo |
Primary outcome
Mindtension EMG values
Time frame: baseline and 1 hour post treatment
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
Time frame: Baseline
ADHD-RS-IV questionnaire ADHD-RS-IV questionnaire
Impulsive dysregulation
Time frame: Baseline
Clinical Global Impression (CGI): Clinical Global Impression - Severity and Clinical Global Impression - Improvement (CGI-S, CGI-I, respectively)
2 secondary outcomes
CBCL
Time frame: Baseline
Changes in treatment
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
Related trials for Attention Deficit Disorder With Hyperactivity
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
RecruitingPhase 3
A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
Attention-deficit/Hyperactivity Disorder, Emotional Dysregulation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MT1 Device in people with Attention Deficit Disorder With Hyperactivity, run by Geha Mental Health Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iris Manor, MD (+97239728600, IManor@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mindtension EMG values (time frame: baseline and 1 hour post treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.