Multiple SclerosisNCT06136923
An Exploratory Study to Evaluate Attention Biases in Adults With Multiple Sclerosis, Breast Cancer, and Lung Cancer
A study testing CT-100-D-004-A and CT-100-D-004-B in people with Multiple Sclerosis and Lung Cancer, run by Click Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Lung Cancer, Breast Cancer
- What is being tested?
- CT-100-D-004-A and CT-100-D-004-B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2023to 6 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis, Lung Cancer, Breast Cancer
- Being tested
- CT-100-D-004-A, CT-100-D-004-B
- Keywords
- Prescription digital therapeutic (PDT), Software as a Medical Device (SaMD), Smartphone app, Attention Biases, Cognition, Multiple Sclerosis, Lung Cancer, Breast Cancer
- Medical subject headings
- Multiple Sclerosis, Lung Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-100-D-004-ADevice
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.
CT-100-D-004-BDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: CT-100-D-004-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline to Week 4
Secondary outcomes (6)
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)
Measured: Baseline to Week 4
Change in Pain Catastrophizing Scale
Change from baseline to Week 4 Pain Catastrophizing Scale (PCS) from 0-30+
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to Week 4
Engagement with Study App
Engagement with the Study App as measured by daily time in the Study App
Measured: Baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start19 Oct 2023
- Primary completion18 Apr 2024
- Study completion6 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Click Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shaheen Lakhan, Study director, Click Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136923
- Sponsor's protocol ID
- CT-100-D-004
- Status last verified
- May 2024
- First submitted
- 1 Nov 2023
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Evaluate Attention Biases in Adults With Multiple Sclerosis, Breast Cancer, and Lung Cancer
- ClinicalTrials.gov ID
- NCT06136923
- Acronym / sponsor ID
- CT-100-D-004
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Click Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 18 Apr 2024 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis with Mobility Limitations Study App A | Experimental | Device: CT-100-D-004-ACognitive 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. |
| Multiple Sclerosis with Mobility Limitations Study App B | Other | Device: CT-100-D-004-BCognitive 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. |
| Multiple Sclerosis without Mobility Limitations Study App A | Experimental | Device: CT-100-D-004-ACognitive 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. |
| Multiple Sclerosis without Mobility Limitations Study App B | Other | Device: CT-100-D-004-BCognitive 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. |
| Oncology Breast Cancer Study App A | Experimental | Device: CT-100-D-004-ACognitive 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. |
| Oncology Breast Cancer Study App B | Other | Device: CT-100-D-004-BCognitive 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. |
| Oncology Lung Cancer Study App A | Experimental | Device: CT-100-D-004-ACognitive 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. |
| Oncology Lung Cancer Study App B | Other | Device: CT-100-D-004-BCognitive 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. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- A participant will be eligible for entry into the study if all of the following criteria are met:
Key exclusion criteria (11 listed)
- A participant will not be eligible for study entry if any of the following criteria are met:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-100-D-004-AAttention 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. | Device | 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-BAttention 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. | Device | 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 |
Primary outcome
Change in Patient Reported Outcomes
Time frame: Baseline to Week 4
Change from baseline to Week 4 in quality of life as measured by PROMIS-29+2 (Patient Reported Outcomes Measurement Information System)
6 secondary outcomes
Change in Pain Severity and Pain Interference
Time frame: Baseline to Week 4
Change in Pain Catastrophizing Scale
Time frame: Baseline to Week 4
Change in indication-specific measures MS
Time frame: Baseline to Week 4
Change in indication-specific measures Cancer
Time frame: Baseline to Week 4
Proportion of participants with an improvement
Time frame: Baseline to Week 4
Engagement with Study App
Time frame: Baseline to Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaheen Lakhan study director
Click Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-100-D-004-A and CT-100-D-004-B in people with Multiple Sclerosis and Lung Cancer, run by Click Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Reported Outcomes (time frame: Baseline to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.