Guided ADHD Therapy for Managing the Extent and Severity of Symptoms

NCT05296473 | Completed

• 1 other identifier: CIP-013
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 13

Brief Summary

The objective of this study is to assess the safety and effectiveness of an at-home, game-based digital therapy for treating adult patients with Attention-Deficit/Hyperactivity Disorder (ADHD).

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

• Test of Variables of Attention (TOVA®) Attention Comparison Score (ACS)

  The TOVA is a standardized, computerized, continuous performance test (CPT). The TOVA Attention Comparison Score (ACS) is a comparison of a subject's scores to scores from a normative ADHD population. A score of \< 0 indicates a subject's performance is similar to that of the normative ADHD population, with a lower score indicating a more severe ADHD profile. A positive change on the TOVA ACS from Day 0 to Day 63 indicates improvement.

  Study Day 0 to Study Day 63

Secondary Outcomes (6)

• ADHD-RS-5 Inattention Subscale with Adult Prompts

  Study Day 0 to Study Day 63

• Cambridge Brain Sciences Token Search

  Study Day 0 to Study Day 63

• Cambridge Brain Sciences Spatial Span

  Study Day 0 to Study Day 63

• Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Working Memory and Inhibit Percentiles

  Study Day 0 to Study Day 63

• Weiss Functional Impairment Rating Scale - Self-Report (WFIRS-S)

  Study Day 0 to Study Day 63

Study Arms (2)

ADHD Therapy

EXPERIMENTAL

Device: ADHD Therapy

Control Therapy

ACTIVE COMPARATOR

Device: Control Therapy

Interventions

ADHD Therapy DEVICE

investigational game-play therapy

ADHD Therapy

Control Therapy DEVICE

control game-play therapy

Control Therapy

Eligibility Criteria

• Age: 22 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects 22-55 years of age
• Male or female
• Confirmed ADHD diagnosis, combined or inattentive type, at Screening based on DSM-5 criteria and established via the MINI-Adult, administered by a trained clinician
• Baseline score on the clinician-rated ADHD-RS total score ≥28
• Not undergoing pharmacological treatment with methylphenidate or amphetamine-based products at time of Screening; or, if undergoing pharmacological treatment, must be willing and appropriate (i.e., not optimally treated in the Investigator's judgement or having issues with tolerability) to wash out of current regimen
• Estimated IQ score ≥80 as assessed by the Kaufmann Brief Intelligence Test, Second Edition (KBIT-II)
• Ability to understand and speak English, follow written and verbal instructions (English), as assessed by the PI and/or Study Coordinator, and give informed consent (English)
• Have ability to connect wireless devices to a functional wireless network on a daily basis
• Ability to comply with all the testing and study requirements

You may not qualify if:

• Current, controlled (requiring restricted medication) or uncontrolled, comorbid psychiatric diagnosis, based on MINI-Adult and subsequent clinical interviewing, with significant symptoms including but not limited to posttraumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder, conduct disorder, or other symptomatic manifestations that in the opinion of the Investigator may confound study data/assessments.
• Patients who are currently treated with a non-stimulant medication for ADHD (i.e., atomoxetine, clonidine, guanfacine, viloxazine)
• Have previously been assessed by TOVA for potential enrollment in a clinical trial.
• Have previously used a videogame-like digital therapy (e.g., Akili EndeavorRxTM) OR Within the last three years, have used a cognitive or brain training platform (e.g., Peak, Brain HQ, Lumosity, Atentiv) for more than two weeks duration
• Known sensitivity to playing video games, such as headaches, dizziness, nausea.
• Initiation within the last 4 weeks of behavioral therapy or neurofeedback, or planned initiation during the study. Patients who have been in behavior therapy or neurofeedback consistently for more than 4 weeks may participate provided their routine is unchanged during the course of the study. Patients planning on changing or initiating behavior therapy or neurofeedback during the course of the study will be excluded.
• Patient is currently considered a suicide risk in the opinion of the Investigator, as measured by C-SSRS at screening (i.e., score of 4 or 5 on C-SSRS)
• Motor condition (e.g., physical deformity of the hands/arms; protheses) that prevents game playing as observed by the Investigator
• Recent history (within the past 12 months) of suspected alcohol or substance abuse or dependence
• Positive urine drug screen
• History of seizures (excluding febrile seizures), or significant motor or vocal tics, including but not limited to Tourette's Disorder and photo-sensitive epilepsy
• Visual acuity that cannot be corrected that prevents or negatively impacts game playing as observed by the Investigator
• Any use of psychoactive drugs (other than stimulant) that in the opinion of the Investigator may confound study data/assessments
• Has participated in a clinical trial within 90 days prior to screening
• Has a family member or close friend/associate also enrolled/currently participating in the same study

Sponsors & Collaborators

• Lumos Labs, Inc.: lead

Study Sites (13)

Melmed Center

Scottsdale, Arizona, 85254, United States

Location

CNS Network

Garden Grove, California, 92845, United States

Location

University of California Davis MIND Institute

Sacramento, California, 95817, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Accel Research Sites - Maitland Clinical Research Unit

Maitland, Florida, 32751, United States

Location

Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

Alivation Research, LLC

Lincoln, Nebraska, 68526, United States

Location

Center of Psychiatry and Behavioral Medicine

Las Vegas, Nevada, 89128, United States

Location

Center for Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Mindpath Care Centers

Raleigh, North Carolina, 27606, United States

Location

CNS Healthcare

Memphis, Tennessee, 38119, United States

Location

FutureSearch Trials of Dallas

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Ann Childress, MD

  Clinical Research of Southern Nevada, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 25, 2022
• Study Start: May 5, 2022
• Primary Completion: March 12, 2024
• Study Completion: March 12, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)