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New controlled trial was funded, this study was no longer needed.
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The proposed study will test the feasibility and tolerability of transcranial direct current stimulation (tDCS) added to a cognitive remediation program in n=100 adults. For 60 cognitive remediation sessions, participants will receive 20 minutes of active tDCS stimulation (up to 4.0 mA, dorsolateral prefrontal cortex or montage dependent on specific area of deficit) while they complete the cognitive training tasks.
Transcranial Direct Current Stimulation (tDCS) is a novel, safe, well-tolerated, and low-cost treatment approach that may enhance the benefits of cognitive remediation. The application of tDCS is a relatively recent therapeutic development that utilizes low amplitude direct currents to induce changes in cortical excitability. To meet this study's objectives, investigators will focus specifically on working memory (WM) in both training and outcome. Limiting training to WM exercises will provide the opportunity to test proof of concept for the combined therapies within this shorter two-week time frame, and maximize the synergistic effect by engaging the same regions as targeted by the tDCS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Remediation | Experimental | For the 20 cognitive remediation sessions, eligible participants will receive 20 minutes of active tDCS stimulation (up to 2.0 mA, dorsolateral prefrontal cortex (dlPFC) motage) while they complete the cognitive training tasks. Once the participant has completed his/her 20 sessions a pre/post treatment assessment measures will be completed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS stimulation | Device | up to 4.0 mA, dorsolateral prefrontal cortex (montage dependent on specific area of deficit) while completing cognitive training tasks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Completing at Least 80% of the Targeted Number of Sessions. | The protocol is designed to have a decision-tree series of checkpoints that must be met in order to proceed at each step | End of treatment (up to 12 weeks) |
| Number of Participants With Treatment Related Adverse Events | End of treatment (up to 12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analogue Scale (VAS) for Pain Score | VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain. | Baseline, end of treatment (up to 12 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
Visual, auditory and motor deficits that would prevent full ability to understand study instructions or operate the tDCS device or study laptop, as judged by treating clinician or study staff
Primary, uncontrolled psychiatric disorder that would influence ability to participate
Poorly controlled epilepsy
Medical device implanted in the head (such as Deep Brain Stimulator) or in the neck (such as a Vagus Nerve Stimulator)
Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed)
Treatment for a communicable skin disorder currently or over the past 12 months
Other serious uncontrolled medical condition (e.g., cancer or acute myocardial infarction)
Wide Range Achievement Test-4th Edition (WRAT-4) Reading Recognition score <85*
Symbol Digit Modalities Test (SDMT) ≥3.0 SD below published norms*
Learned English language after 12 years of age
Pregnant or breastfeeding
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| Name | Affiliation | Role |
|---|---|---|
| Leigh Charvet, MD | New York University Medical Center Institutional Review Boards | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University Medical Center | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30890162 | Derived | Pilloni G, Shaw M, Feinberg C, Clayton A, Palmeri M, Datta A, Charvet LE. Long term at-home treatment with transcranial direct current stimulation (tDCS) improves symptoms of cerebellar ataxia: a case report. J Neuroeng Rehabil. 2019 Mar 19;16(1):41. doi: 10.1186/s12984-019-0514-z. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Remediation | For the 20 cognitive remediation sessions, eligible participants will receive 20 minutes of active tDCS stimulation (up to 2.0 mA, dorsolateral prefrontal cortex (dlPFC) motage) while they complete the cognitive training tasks. Once the participant has completed his/her 20 sessions a pre/post treatment assessment measures will be completed. tDCS stimulation: up to 4.0 mA, dorsolateral prefrontal cortex (montage dependent on specific area of deficit) while completing cognitive training tasks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Remediation | For the 20 cognitive remediation sessions, eligible participants will receive 20 minutes of active tDCS stimulation (up to 2.0 mA, dorsolateral prefrontal cortex (dlPFC) motage) while they complete the cognitive training tasks. Once the participant has completed his/her 20 sessions a pre/post treatment assessment measures will be completed. tDCS stimulation: up to 4.0 mA, dorsolateral prefrontal cortex (montage dependent on specific area of deficit) while completing cognitive training tasks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Completing at Least 80% of the Targeted Number of Sessions. | The protocol is designed to have a decision-tree series of checkpoints that must be met in order to proceed at each step | Posted | Count of Participants | Participants | End of treatment (up to 12 weeks) |
|
12 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive Remediation | For the 20 cognitive remediation sessions, eligible participants will receive 20 minutes of active tDCS stimulation (up to 2.0 mA, dorsolateral prefrontal cortex (dlPFC) motage) while they complete the cognitive training tasks. Once the participant has completed his/her 20 sessions a pre/post treatment assessment measures will be completed. tDCS stimulation: up to 4.0 mA, dorsolateral prefrontal cortex (montage dependent on specific area of deficit) while completing cognitive training tasks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tingling Sensation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leigh Charvet, MD | NYU Langone Health | 9294555141 | Leigh.Charvet@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 30, 2019 | Apr 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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20 sessions of cognitive remediation while receiving 20 minutes of up to 2.0 mA tDCS using a DLPFC montage
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|
| Change in Negative Affect Score From the Positive and Negative Affect Scale (PANAS) | This brief scale is comprised of 10 items measuring negative affect (e.g., upset, afraid). Individual items are scored 1-5, 1 being "very slightly or not at all" and 5 being "Extremely". The negative affect score is calculated by finding the sum of the 10 negative items. Scores range from 10 - 50. For the total negative score, a lower score indicates less of a negative affect. | Baseline, end of treatment (up to 12 weeks) |
| Change in Positive Affect Score From the Positive and Negative Affect Scale (PANAS) | This brief scale is comprised of 10 items measuring positive affect (e.g., excited, inspired). Individual items are scored 1-5, 1 being "very slightly or not at all" and 5 being "Extremely". The positive affect score is calculated by finding the sum of the 10 positive items. Scores range from 10 - 50. For the total positive score, a higher score indicates more of a positive affect. | Baseline, end of treatment (up to 12 weeks) |
| Change in Symbol Digit Modalities Test (SDMT) Score | The SDMT is a cognitive processing speed test. Participants are given a key of nine symbol-digit pairs along with a sequence of symbols. They are then asked to use the key to match as many symbols in the sequence to their corresponding numbers as possible within 90 seconds. The score is the number of correctly coded items from 0-110 in 90 seconds. Lower scores indicate cognitive decline. | Baseline, end of treatment (up to 12 weeks) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Participants With Treatment Related Adverse Events | Posted | Count of Participants | Participants | End of treatment (up to 12 weeks) |
|
|
|
| Secondary | Change in Visual Analogue Scale (VAS) for Pain Score | VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain. | Posted | Mean | Standard Deviation | score on a scale | Baseline, end of treatment (up to 12 weeks) |
|
|
|
| Secondary | Change in Negative Affect Score From the Positive and Negative Affect Scale (PANAS) | This brief scale is comprised of 10 items measuring negative affect (e.g., upset, afraid). Individual items are scored 1-5, 1 being "very slightly or not at all" and 5 being "Extremely". The negative affect score is calculated by finding the sum of the 10 negative items. Scores range from 10 - 50. For the total negative score, a lower score indicates less of a negative affect. | Posted | Mean | Standard Deviation | score on a scale | Baseline, end of treatment (up to 12 weeks) |
|
|
|
| Secondary | Change in Positive Affect Score From the Positive and Negative Affect Scale (PANAS) | This brief scale is comprised of 10 items measuring positive affect (e.g., excited, inspired). Individual items are scored 1-5, 1 being "very slightly or not at all" and 5 being "Extremely". The positive affect score is calculated by finding the sum of the 10 positive items. Scores range from 10 - 50. For the total positive score, a higher score indicates more of a positive affect. | Posted | Mean | Standard Deviation | score on a scale | Baseline, end of treatment (up to 12 weeks) |
|
|
|
| Secondary | Change in Symbol Digit Modalities Test (SDMT) Score | The SDMT is a cognitive processing speed test. Participants are given a key of nine symbol-digit pairs along with a sequence of symbols. They are then asked to use the key to match as many symbols in the sequence to their corresponding numbers as possible within 90 seconds. The score is the number of correctly coded items from 0-110 in 90 seconds. Lower scores indicate cognitive decline. | Posted | Mean | Standard Deviation | score on a scale | Baseline, end of treatment (up to 12 weeks) |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 14 |
| 15 |
| Itching Sensation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Warmth Sensation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D007154 | Immune System Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |