An Exploratory Study to Evaluate Attention Biases in Adults With Multiple Sclerosis, Breast Cancer, and Lung Cancer

NCT06136923 | Completed

• 1 other identifier: CT-100-D-004
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

CT-100 is a platform that provides interactive, software based therapeutic components that may be used as part of a treatment in future software-based prescription digital therapeutics. One class of CT-100 components are Digital Neuro-activation and Modulation (DiNaMo) components. DiNaMo components target key neural systems (including but not limited to systems related to sensory-, perceptual-, affective-, pain-, attention-, cognitive control, social- and self-processing) to optimally improve a participant's health.

Conditions

Multiple Sclerosis; Lung Cancer; Breast Cancer

Keywords

Prescription digital therapeutic (PDT); Software as a Medical Device (SaMD); Smartphone app; Attention Biases; Cognition; Multiple Sclerosis; Lung Cancer; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Patient Reported Outcomes

  Change from baseline to Week 4 in quality of life as measured by PROMIS-29+2 (Patient Reported Outcomes Measurement Information System)

  Baseline to Week 4

Secondary Outcomes (6)

• Change in Pain Severity and Pain Interference

  Baseline to Week 4

• Change in Pain Catastrophizing Scale

  Baseline to Week 4

• Change in indication-specific measures MS

  Baseline to Week 4

• Change in indication-specific measures Cancer

  Baseline to Week 4

• Proportion of participants with an improvement

  Baseline to Week 4

Study Arms (8)

Multiple Sclerosis with Mobility Limitations Study App A

EXPERIMENTAL

Cognitive Training App CT-100-D-004-A uses implicit training with audiovisual stimuli to potentially redirect and modulate attention processes. This intervention is designed to help improve cognitive capabilities as well as redirect attentional biases to make participants less sensitive to distressing stimuli for multiple sclerosis with mobility limitations.

Device: CT-100-D-004-A

Multiple Sclerosis with Mobility Limitations Study App B

OTHER

Cognitive Training App CT-100-D-004-B uses implicit training with verbal processing exercises to potentially redirect and modulate attention processes. This intervention is designed to help improve cognitive capabilities as well as redirect attentional biases to make participants less sensitive to distressing stimuli for multiple sclerosis with mobility limitations.

Device: CT-100-D-004-B

Multiple Sclerosis without Mobility Limitations Study App A

EXPERIMENTAL

Cognitive Training App CT-100-D-004-A uses implicit training with audiovisual stimuli to potentially redirect and modulate attention processes. This intervention is designed to help improve cognitive capabilities as well as redirect attentional biases to make participants less sensitive to distressing stimuli for multiple sclerosis without mobility limitations.

Device: CT-100-D-004-A

Multiple Sclerosis without Mobility Limitations Study App B

OTHER

Cognitive Training App CT-100-D-004-B uses implicit training with verbal processing exercises to potentially redirect and modulate attention processes. This intervention is designed to help improve cognitive capabilities as well as redirect attentional biases to make participants less sensitive to distressing stimuli for multiple sclerosis without mobility limitations.

Device: CT-100-D-004-B

Oncology Breast Cancer Study App A

EXPERIMENTAL

Cognitive Training App CT-100-D-004-A uses implicit training with audiovisual stimuli to potentially redirect and modulate attention processes. This intervention is designed to help improve cognitive capabilities as well as redirect attentional biases to make participants less sensitive to distressing stimuli for breast cancer.

Device: CT-100-D-004-A

Oncology Breast Cancer Study App B

OTHER

Cognitive Training App CT-100-D-004-B uses implicit training with verbal processing exercises to potentially redirect and modulate attention processes. This intervention is designed to help improve cognitive capabilities as well as redirect attentional biases to make participants less sensitive to distressing stimuli for breast cancer.

Device: CT-100-D-004-B

Oncology Lung Cancer Study App A

EXPERIMENTAL

Cognitive Training App CT-100-D-004-A uses implicit training with audiovisual stimuli to potentially redirect and modulate attention processes. This intervention is designed to help improve cognitive capabilities as well as redirect attentional biases to make participants less sensitive to distressing stimuli for lung cancer.

Device: CT-100-D-004-A

Oncology Lung Cancer Study App B

OTHER

Cognitive Training App CT-100-D-004-B uses implicit training with verbal processing exercises to potentially redirect and modulate attention processes. This intervention is designed to help improve cognitive capabilities as well as redirect attentional biases to make participants less sensitive to distressing stimuli for lung cancer.

Device: CT-100-D-004-B

Interventions

CT-100-D-004-A DEVICE

Attention Biases App CT-100-D-004-A Digital Neuro-activation and Modulation (DiNaMo) component uses implicit training to redirect and strengthen attention processes. This intervention can help improve cognitive capabilities as well as redirect attentional biases to make participants less sensitive to distressing stimuli.

Multiple Sclerosis with Mobility Limitations Study App A; Multiple Sclerosis without Mobility Limitations Study App A; Oncology Breast Cancer Study App A; Oncology Lung Cancer Study App A

CT-100-D-004-B DEVICE

Attention Biases App CT-100-D-004-B Digital Neuro-activation and Modulation (DiNaMo) component uses implicit training to redirect and strengthen attention processes. This intervention can help improve cognitive capabilities as well as redirect attentional biases to make participants less sensitive to distressing stimuli.

Multiple Sclerosis with Mobility Limitations Study App B; Multiple Sclerosis without Mobility Limitations Study App B; Oncology Breast Cancer Study App B; Oncology Lung Cancer Study App B

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A participant will be eligible for entry into the study if all of the following criteria are met:
• Fluent in written and spoken English, confirmed by ability to read, understand, and sign the informed consent form
• Lives in the United States
• Adult between 22 and 65 years old
• Meets indication-specific including criteria, as reported by the study participant with adequate clinical documentation (to be provided to the study team upon request)
• Has an active email address and is willing and able to receive and respond to email messages
• Has access to an internet connection during the study duration
• Has an active PayPal account to receive study compensation, or is willing to create one
• Willing and able to comply with study protocol and assessments
• Is the sole user of an iPhone with an iPhone operating system (iOS) version 14 or later or a smartphone with an Android operating system (OS) version 10 or later for the duration of the study
• Is willing and able to receive Short Message Service (SMS) text messages and notifications on their smartphone
• Has access to operating headphones

You may not qualify if:

• A participant will not be eligible for study entry if any of the following criteria are met:
• Visual, dexterity or cognitive deficit so severe that it precludes the use of an App-based reaction time-based activity per investigator judgment
• Severe psychiatric disorder involving a history of psychosis (e.g., schizophrenia, bipolar disorder, severe personality disorders)
• Psychiatric hospitalization in the past 6 months
• Participation in any research study (including studies on psychotherapy, mindfulness, cognitive training or pharmacological treatment) during the past 3 months
• Initiation or change in primary disease-specific medication within 30 days prior to entering the study
• Planning the introduction of new therapies (including studies on psychotherapy, mindfulness, cognitive training or pharmacological treatment) during the study duration (6 weeks)
• Anticipating a change in current pharmacological or psychotherapy treatment regimen during the study period (6 weeks)
• Self-reported substance use disorder within the past 1 year
• Severe neurological disorders impairing brain function (e.g., previous stroke, dementia, primary brain function, brain metastases, Alzheimer's disease, Parkinson's disease, history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities)
• Mild, moderate, severe or profound unilateral or bilateral hearing loss

Sponsors & Collaborators

• Click Therapeutics, Inc.: lead

Study Sites (1)

Click Therapeutics

New York, New York, 10013, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Lung Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Shaheen Lakhan

  Click Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 18, 2023
• Study Start: October 19, 2023
• Primary Completion: April 18, 2024
• Study Completion: May 6, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

US (1)