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An Adjunct Study to Assess Guided ADHD Therapy for Managing the Extent and Severity of Symptoms (A-GAMES)

Primary Purpose

ADHD

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ADHD Therapy
Sponsored by
Lumos Labs, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 22-55 years of age (Cohort I) or 18-21 years of age (Cohort II) 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 total score on the DSM 5 Inattentive Symptoms, DSM 5 Hyperactive - Impulsive Symptoms and ADHD Index subscales of the Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) ≥24 Current, stable use of an FDA approved pharmacological treatment for ADHD for at least 4 weeks prior to screening, but ADHD condition inadequately managed by that medication 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 daily Have access to a computer or smart device (e.g., phone, tablet) with internet access and a Google Chrome web browser Ability to comply with all the testing and study requirements Exclusion Criteria: Unstable/uncontrolled, comorbid psychiatric diagnosis, based on clinical interviewing, with significant current active symptoms including but not limited to posttraumatic stress disorder, schizophrenia spectrum and other psychotic disorders, bipolar disorder, autism spectrum 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 Inadequate IQ to participate in the study as estimated by Investigator (i.e., inability to read/understand the informed consent; inability to understand how the device and therapy (games) work) PHQ-9 scores ≥16 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 ADHD medication) 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 Any other condition that in the opinion of the Investigator may confound study data/assessments

Sites / Locations

  • CNS Healthcare of JacksonvilleRecruiting
  • Accel Clinical Research SitesRecruiting
  • Rochester Center for Behavioral Medicine (RCBM)Recruiting
  • Midwest Research GroupRecruiting
  • Hassman Research InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ADHD Therapy

Arm Description

Outcomes

Primary Outcome Measures

Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) Inattentive Symptoms subscale
The Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) has 66 items with multiple subscales.

Secondary Outcome Measures

Adult ADHD Self-Report Scale (ASRS) Inattentive Symptoms Subscale
The World Health Organization Adult Self-Report Scale (ASRS) symptom checklist is an 18-item tool to screen for probable ADHD in adults. The ASRS checklist asks respondents to indicate how they have felt and conducted themselves over the past 6 months in terms of frequency of inattention or hyperactivity symptoms, which are rated from 0 ("never") to 4 ("very often"). The checklist is divided into two parts and results in a "Part A" inattention subscore (range 0-36), a "Part B" hyperactivity/ impulsivity subscore (range 0-36), and a total score based on the full scale (range 0-72).
Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) ADHD Symptoms Total subscale
The Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) has 66 items with multiple subscales.
Sheehan Disability Scale (SDS)
The Sheehan Disability Scale is a five-item, self-rated questionnaire designed to measure the extent to which a patient's disability due to an illness or health problem interferes with work/school, social life/leisure activities, and family life/home responsibilities.

Full Information

First Posted
March 24, 2023
Last Updated
May 19, 2023
Sponsor
Lumos Labs, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05805176
Brief Title
An Adjunct Study to Assess Guided ADHD Therapy for Managing the Extent and Severity of Symptoms
Acronym
A-GAMES
Official Title
An Adjunct Study to Assess Guided ADHD Therapy for Managing the Extent and Severity of Symptoms - A Prospective, Multicenter, Open Label, Single Arm, Intervention Study to Assess Efficacy and Safety of an At-home, Game-based Digital Therapy for Treating Clinical Symptoms of Adult Patients With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lumos Labs, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
194 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ADHD Therapy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ADHD Therapy
Intervention Description
investigational game-play therapy
Primary Outcome Measure Information:
Title
Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) Inattentive Symptoms subscale
Description
The Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) has 66 items with multiple subscales.
Time Frame
Study Day 0 to Study Day 63
Secondary Outcome Measure Information:
Title
Adult ADHD Self-Report Scale (ASRS) Inattentive Symptoms Subscale
Description
The World Health Organization Adult Self-Report Scale (ASRS) symptom checklist is an 18-item tool to screen for probable ADHD in adults. The ASRS checklist asks respondents to indicate how they have felt and conducted themselves over the past 6 months in terms of frequency of inattention or hyperactivity symptoms, which are rated from 0 ("never") to 4 ("very often"). The checklist is divided into two parts and results in a "Part A" inattention subscore (range 0-36), a "Part B" hyperactivity/ impulsivity subscore (range 0-36), and a total score based on the full scale (range 0-72).
Time Frame
Study Day 0 to Study Day 63
Title
Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) ADHD Symptoms Total subscale
Description
The Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) has 66 items with multiple subscales.
Time Frame
Study Day 0 to Study Day 63
Title
Sheehan Disability Scale (SDS)
Description
The Sheehan Disability Scale is a five-item, self-rated questionnaire designed to measure the extent to which a patient's disability due to an illness or health problem interferes with work/school, social life/leisure activities, and family life/home responsibilities.
Time Frame
Study Day 0 to Study Day 63

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 22-55 years of age (Cohort I) or 18-21 years of age (Cohort II) 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 total score on the DSM 5 Inattentive Symptoms, DSM 5 Hyperactive - Impulsive Symptoms and ADHD Index subscales of the Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) ≥24 Current, stable use of an FDA approved pharmacological treatment for ADHD for at least 4 weeks prior to screening, but ADHD condition inadequately managed by that medication 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 daily Have access to a computer or smart device (e.g., phone, tablet) with internet access and a Google Chrome web browser Ability to comply with all the testing and study requirements Exclusion Criteria: Unstable/uncontrolled, comorbid psychiatric diagnosis, based on clinical interviewing, with significant current active symptoms including but not limited to posttraumatic stress disorder, schizophrenia spectrum and other psychotic disorders, bipolar disorder, autism spectrum 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 Inadequate IQ to participate in the study as estimated by Investigator (i.e., inability to read/understand the informed consent; inability to understand how the device and therapy (games) work) PHQ-9 scores ≥16 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 ADHD medication) 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 Any other condition that in the opinion of the Investigator may confound study data/assessments
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bob Schafer, PhD
Phone
(530) 746-8565
Email
bschafer@lumoslabs.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg Mattingly, MD
Organizational Affiliation
Midwest Research Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
CNS Healthcare of Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Name
Accel Clinical Research Sites
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33803
Country
United States
Individual Site Status
Recruiting
Facility Name
Rochester Center for Behavioral Medicine (RCBM)
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Individual Site Status
Recruiting
Facility Name
Midwest Research Group
City
Brentwood
State/Province
Missouri
ZIP/Postal Code
63144
Country
United States
Individual Site Status
Recruiting
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

An Adjunct Study to Assess Guided ADHD Therapy for Managing the Extent and Severity of Symptoms

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