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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Breast Cancer; Lung Cancer
• Intervention / Treatment: Device: CT-100-D-004-A; Device: CT-100-D-004-B

Detailed Description

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.

Targeted cognitive training is used to reduce symptoms relevant to multiple sclerosis (MS) and cancer. Biases to direct attention towards or away from certain stimuli can exacerbate a variety of symptoms in many different indications. For example, in chronic pain conditions, patients are more attentive to pain-related stimuli, which can lead to hypersensitization. Similarly, hypersensitivity to threat-related stimuli can exacerbate anxiety.

In this treatment, users are trained to re-orient attention away from negative stimuli, such as pain- or threat-related stimuli.

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10013
      • Click Therapeutics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• A participant will be eligible for entry into the study if all of the following criteria are met:

  1. Fluent in written and spoken English, confirmed by ability to read, understand, and sign the informed consent form
  2. Lives in the United States
  3. Adult between 22 and 65 years old
  4. Meets indication-specific including criteria, as reported by the study participant with adequate clinical documentation (to be provided to the study team upon request)
  5. Has an active email address and is willing and able to receive and respond to email messages
  6. Has access to an internet connection during the study duration
  7. Has an active PayPal account to receive study compensation, or is willing to create one
  8. Willing and able to comply with study protocol and assessments
  9. 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
  10. Is willing and able to receive Short Message Service (SMS) text messages and notifications on their smartphone
  11. Has access to operating headphones

Exclusion Criteria:

• A participant will not be eligible for study entry if any of the following criteria are met:

  1. Visual, dexterity or cognitive deficit so severe that it precludes the use of an App-based reaction time-based activity per investigator judgment
  2. Severe psychiatric disorder involving a history of psychosis (e.g., schizophrenia, bipolar disorder, severe personality disorders)
  3. Psychiatric hospitalization in the past 6 months
  4. Participation in any research study (including studies on psychotherapy, mindfulness, cognitive training or pharmacological treatment) during the past 3 months
  5. Initiation or change in primary disease-specific medication within 30 days prior to entering the study
  6. Planning the introduction of new therapies (including studies on psychotherapy, mindfulness, cognitive training or pharmacological treatment) during the study duration (6 weeks)
  7. Anticipating a change in current pharmacological or psychotherapy treatment regimen during the study period (6 weeks)
  8. Self-reported substance use disorder within the past 1 year
  9. 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)
  10. Mild, moderate, severe or profound unilateral or bilateral hearing loss

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multiple Sclerosis with Mobility Limitations Study App A; 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; 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.
Other: Multiple Sclerosis with Mobility Limitations Study App B; 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; 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.
Experimental: Multiple Sclerosis without Mobility Limitations Study App A; 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; 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.
Other: Multiple Sclerosis without Mobility Limitations Study App B; 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; 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.
Experimental: Oncology Breast Cancer Study App A; 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; 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.
Other: Oncology Breast Cancer Study App B; 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; 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.
Experimental: Oncology Lung Cancer Study App A; 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; 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.
Other: Oncology Lung Cancer Study App B; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Severity and Pain Interference	Change from baseline to Week 4 in pain severity and pain interference as measured by the Brief Pain Inventory (BPI)	Baseline to Week 4
Change in Pain Catastrophizing Scale	Change from baseline to Week 4 Pain Catastrophizing Scale (PCS) from 0-30+	Baseline to Week 4
Change in indication-specific measures MS	Change from baseline to Week 4 in indication-specific measures: Symbol Digit Modalities Test (SDMT) for MS	Baseline to Week 4
Change in indication-specific measures Cancer	Change from baseline to Week 4 in indication-specific measures: Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) for cancer	Baseline to Week 4
Proportion of participants with an improvement	Proportion of participants with an improvement as measured by the Global Rating of Change (GRC) score from -5 to 5 at Week 4	Baseline to Week 4
Engagement with Study App	Engagement with the Study App as measured by daily time in the Study App	Baseline to Week 4

Collaborators and Investigators

• Sponsor: Click Therapeutics, Inc.
• Investigators: Study Director: Shaheen Lakhan, Click Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2023
• Primary Completion (Actual): April 18, 2024
• Study Completion (Actual): May 6, 2024

Study Registration Dates

• First Submitted: November 1, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Breast Cancer; Lung Cancer; Cognition; Smartphone app; Software as a Medical Device (SaMD); Prescription digital therapeutic (PDT); Attention Biases
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Skin Diseases; Respiratory Tract Diseases; Immune System Diseases; Neoplasms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Lung Diseases; Neoplasms by Site; Breast Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Multiple Sclerosis; Sclerosis; Breast Neoplasms; Lung Neoplasms
• Other Study ID Numbers: CT-100-D-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No