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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
A participant will be eligible for entry into the study if all of the following criteria are met:
Exclusion Criteria:
A participant will not be eligible for study entry if any of the following criteria are met:
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| Name | Affiliation | Role |
|---|---|---|
| Shaheen Lakhan | Click Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Click Therapeutics | New York | New York | 10013 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D008175 | Lung Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| 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. |
|
| 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. |
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| 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. |
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| 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. |
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|
| 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. |
|
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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |