A study of brain stimulation in adults with attention deficit hyperactivity disorder

Not Applicable

• Conditions: Adult attention deficit hyperactivity disorder (ADHD); Mental and Behavioural Disorders

• Registration Number: ISRCTN85247318
• Lead Sponsor: eurode Labs Pty. Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-20
• Last Update Posted: 8 January 2024
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Male and Female adults aged between 18-35 years old.
2. Individuals with unmedicated ADHD, who have not taken stimulant and non-stimulant ADHD medications for at least 30 days, and have t-scores > 70 on the CAARS ADHD Index measured at screening.

Exclusion Criteria

1. CAARS ADHD index t-scores < 71.
2. English is not their primary language
3. Individuals who may be pregnant or are planning to become pregnant during the 42-day period of study
4. Individuals self-reporting any of the following conditions:
4.1. Acute psychiatric disorders (e.g., psychosis, schizophrenia)
4.2. Substance abuse disorder
4.3. Autism diagnosis
4.4. Anxiety disorders hindering participation in face-to-face activities involving wearing a clinical headset
4.5. History of unprovoked seizures, epilepsy diagnosis, or having a first-degree relative with such conditions
4.6. Traumatic brain injury, brain tumors, or brain lesions/skull abnormalities 3.7. Serious medical conditions, such as cancer
4.8. Current use of psychoactive medications
4.9. Presence of metallic implants in the body
4.10. Severe scalp or facial skin conditions, such as eczema

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ADHD symptom severity measured using the Conners Adult ADHD Rating Scales (CAARS) DSM-IV ADHD Symptoms Total score on Day 1, Day 14, Day 28, and Day 42.

Secondary Outcome Measures

Name	Time	Method
1.CAARS DSM-IV Inattentive Symptoms score measured on Day 1, Day 14, Day 28, and Day 42.<br>2.CAARS DSM-IV Hyperactive-Impulsive Symptoms score measured on Day 1, Day 14, Day 28, and Day 42. <br>3.Cognitive function measured by the Tests of Variables of Attention and Digit Span on Day 1 and Day 28. <br>4.Performance on cognitive training tasks measured on Days 1-28. <br>5.Functional impairment measured with the Weiss Functional Impairment Rating Scale – Self Report (WFIRS-S) on Day 1, Day 14, Day 28, and Day 42. <br>6.Brain activity measured by the investigational device on Days 1-28. <br>7.Feasibility of the investigational device (inclusive of collection of adverse events) measured on Day 28. <br>8.Depression, anxiety, and stress as measured by the DASS-21 on Day 1, Day 14, Day 28, and Day 42. <br>