ADHD
Conditions
Brief 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.
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. .
Interventions
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 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.
DRUGMethylphenidate
Methylphenidate will be administered to each of the study participants in both groups in one of the two days on the study selected randomly.
Sponsors
Brainmarc Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurements of brain electrical signal in Micro volt. | 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. |
Countries
Israel
Outcome results
None listed