ADHDNCT02625805
Evaluation of Use of Brain Activity Monitoring Dynamics in ADHD
A study testing EEG monitoring (MindWave by NeuroSky), EEG monitoring (EPOC by Emotiv) and Methylphenidate in people with ADHD, run by Brainmarc Ltd. at 1 site in Israel.
Trial summary
This study evaluates the ability to support diagnosis and monitor of the dynamics in ADD/ADHD subjects with an easy to use EEG Device. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- What is being tested?
- EEG monitoring (MindWave by NeuroSky), EEG monitoring (EPOC by Emotiv) and Methylphenidate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2016to Jan 2017
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or Female, aged 18 -45 years.
- Able and willing to comply with all study requirements.
- Diagnosed with ADD/ADHD based on clinical evaluation based on the questionnaires:
- Adult ADHD Self-Report Scale (ASRS)
- Wender-Utah Rating Scale
- Positive And Negative Affect Schedule (PANAS)
Who cannot join
- Diagnosed with Psychotic or bipolar disorder.
- Diagnosed with a substantial Neurological disorder or general medical condition with an effect on EEG patterns such as Epilepsy or stroke
- A user of recreational or illicit drugs or has had a recent history (six months) of drug or alcohol abuse or dependence.
- Cognitive impairment.
- Hearing disorder and/or known ear drum impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Ability for Monitoring Dynamics in ADD/ADHD With an Easy to Use EEG
This study evaluates the ability to support diagnosis and monitor of the dynamics in ADD/ADHD subjects with an easy to use EEG Device.
Read the detailed description
The study will be conducted in two arms (arm I and arm II). In arm I, participants diagnosed with ADD/ADHD. In arm II, healthy participants.
The status of the participants will be evaluated with questionnaires computerized test and EEG characteristics will be collected for all study participants. .
- Conditions
- ADHD
- Being tested
- EEG monitoring (MindWave by NeuroSky), EEG monitoring (EPOC by Emotiv), Methylphenidate
- 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.
EEG monitoring (MindWave by NeuroSky)Device
EEG evaluation will be conducted for duration of 10 minutes. 5 minutes without auditory stimulation and 5 minutes with auditory stimulation performed using standard headphone or earphones to reduce external noises. Additional EEG monitoring will be performed during performance of a computerized test using MindWave Headset.
EEG monitoring (EPOC by Emotiv)Device
EEG evaluation will be conducted for duration of 10 minutes. 5 minutes without auditory stimulation and 5 minutes with auditory stimulation performed using standard headphone or earphones to reduce external noises.
MethylphenidateDrug
Methylphenidate will be administered to each of the study participants in both groups in one of the two days on the study selected randomly.
| Study group | Role | What they receive |
|---|---|---|
| Participants diagnosed with ADD/ADHD | Experimental | EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv) and Methylphenidate administration Receives: Device: EEG monitoring (MindWave by NeuroSky); Device: EEG monitoring (EPOC by Emotiv); Drug: Methylphenidate |
| Healthy participants | Experimental | EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv) and Methylphenidate administration Receives: Device: EEG monitoring (MindWave by NeuroSky); Device: EEG monitoring (EPOC by Emotiv); Drug: Methylphenidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements of brain electrical signal in Micro volt.
Measurements of brain electrical signal in Micro volt will be quantified by an algorithm and correlated to ADHD state as evaluated by participants questionnaires, and computerized test.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startApr 2016
- Primary completionOct 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brainmarc Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuval Bloch, MD, Principal investigator, Shalvata Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625805
- Sponsor's protocol ID
- CLD5
- Status last verified
- Jul 2016
- First submitted
- 7 Dec 2015
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Ability for Monitoring Dynamics in ADD/ADHD With an Easy to Use EEG
- ClinicalTrials.gov ID
- NCT02625805
- Acronym / sponsor ID
- CLD5
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Brainmarc Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 9 Dec 2015 (estimated)
- 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.
This study evaluates the ability to support diagnosis and monitor of the dynamics in ADD/ADHD subjects with an easy to use EEG Device.
Detailed description
The study will be conducted in two arms (arm I and arm II). In arm I, participants diagnosed with ADD/ADHD. In arm II, healthy participants.
The status of the participants will be evaluated with questionnaires computerized test and EEG characteristics will be collected for all study participants. .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants diagnosed with ADD/ADHD | Experimental | Device: EEG monitoring (MindWave by NeuroSky), Device: EEG monitoring (EPOC by Emotiv), Drug: MethylphenidateEEG monitoring (MindWave by NeuroSky and EPOC by Emotiv) and Methylphenidate administration |
| Healthy participants | Experimental | Device: EEG monitoring (MindWave by NeuroSky), Device: EEG monitoring (EPOC by Emotiv), Drug: MethylphenidateEEG monitoring (MindWave by NeuroSky and EPOC by Emotiv) and Methylphenidate administration |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or Female, aged 18 -45 years.
- Able and willing to comply with all study requirements.
- Adult ADHD Self-Report Scale (ASRS)
- Wender-Utah Rating Scale
- Positive And Negative Affect Schedule (PANAS)
Key exclusion criteria (5 listed)
- Diagnosed with Psychotic or bipolar disorder.
- Diagnosed with a substantial Neurological disorder or general medical condition with an effect on EEG patterns such as Epilepsy or stroke
- A user of recreational or illicit drugs or has had a recent history (six months) of drug or alcohol abuse or dependence.
- Cognitive impairment.
- Hearing disorder and/or known ear drum impairment.
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 |
|---|---|---|
| EEG monitoring (MindWave by NeuroSky)EEG evaluation will be conducted for duration of 10 minutes. 5 minutes without auditory stimulation and 5 minutes with auditory stimulation performed using standard headphone or earphones to reduce external noises. Additional EEG monitoring will be performed during performance of a computerized test using MindWave Headset. | Device | Healthy participants, Participants diagnosed with ADD/ADHD |
| EEG monitoring (EPOC by Emotiv)EEG evaluation will be conducted for duration of 10 minutes. 5 minutes without auditory stimulation and 5 minutes with auditory stimulation performed using standard headphone or earphones to reduce external noises. | Device | Healthy participants, Participants diagnosed with ADD/ADHD |
| MethylphenidateMethylphenidate will be administered to each of the study participants in both groups in one of the two days on the study selected randomly. | Drug | Healthy participants, Participants diagnosed with ADD/ADHD |
Primary outcome
Measurements of brain electrical signal in Micro volt.
Time frame: 2 weeks
Measurements of brain electrical signal in Micro volt will be quantified by an algorithm and correlated to ADHD state as evaluated by participants questionnaires, and computerized test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
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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.
Yuval Bloch, MD principal investigator
Shalvata Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG monitoring (MindWave by NeuroSky), EEG monitoring (EPOC by Emotiv) and Methylphenidate in people with ADHD, run by Brainmarc Ltd. 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 16 Jun 2017. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurements of brain electrical signal in Micro volt. (time frame: 2 weeks). 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 16 Jun 2017.