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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00050 | Registry Identifier | NCI Clinical Trial Registration Program |
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A common and potentially debilitating late effect of childhood cancer treatment is neurocognitive impairment, frequently in the domain of executive dysfunction, which can limit educational attainment, employment, and quality of life. Among the survivors of childhood acute lymphoblastic leukemia (ALL) in the SJLIFE cohort, the frequency of executive function impairment has been shown as high as 58.8%, with moderate to severe impairment as high as 33.5%, and risk for impairment increased with time from diagnosis. Given the potential of pervasive impact of neurocognitive impairment on daily life, interventions directed at reducing neurocognitive dysfunction among childhood cancer survivors with long-term follow-up are needed. This study examines the potential feasibility and efficacy of a novel intervention to improve executive function.
Primary Objectives:
Secondary Objectives:
tDCS is a form of non-invasive brain stimulation and is a potentially useful tool to enhance cognitive function. This study uses an at-home intervention of tDCS and cognitive training and examines its potential usefulness at improving executive function in ALL survivors.
Investigators will use tDCS to apply a low electrical current to the participant's scalp in the area of the brain associated with fluent and flexible thinking. The current may make that area of the brain work better for a short period of time. During this time, the participant will play computer games designed to train the brain to work more fluently flexibly. Researchers at St. Jude Children's Research Hospital want to see if pairing the electrical stimulation with the brain games at home is a feasible method to improve cognitive abilities in long-term survivors of childhood ALL.
In the first part of this study, the short-term effect of tDCS intervention will be evaluated in the clinical setting using a randomized cross-over trial. The survivors will be randomized to receive either the tDCS intervention or Sham on day 1, with the other treatment given on day 2. Neurocognitive testing will be conducted within two hours of completing stimulation each day.
In the second part of this study, the feasibility and potential efficacy of self-administration of the tDCS intervention paired with cognitive training will be evaluated over 5 weeks. Research participants will be taught to use the mobile tDCS device and will be provided one to take home. The device will be programmed by the investigators in advance to control the intensity and duration of the stimulation. The research participants will use the device twice per week as directed. Within two hours of completing each tDCS session participants will complete 20 minutes of cognitive training using a mobile app installed on an iPad. Neurocognitive testing will be conducted pre- and post- intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS on Day 1 | Active Comparator | On day one, participants will be randomized to receive the transcranial Direct Current Stimulation (tDCS) intervention. On day two, participants receive sham intervention. On both days 1 and 2, within two hours of completing the intervention, participants will complete cognitive assessment. In the second phase of the trial, participants will be evaluated over 5 weeks using a mobile tDCS device and Brain Games Stimulation twice per week. Within two hours of completing each tDCS session, participants will complete 20 minutes of cognitive training using a mobile application installed on an iPad. Cognitive assessment will be conducted pre- and post-intervention using remote assessment. |
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| tDCS on Day 2 | Active Comparator | On day one, participants will be randomized to receive sham intervention. On day two, participants receive the transcranial Direct Current Stimulation (tDCS) intervention. On both days 1 and 2, within two hours of completing the intervention, participants will complete cognitive assessment. The second phase of the trial will be conducted the same as for participants in the tDCS on Day 1 arm. Participants will be evaluated over 5 weeks using a mobile tDCS device and Brain Games Stimulation twice per week. Within two hours of completing each tDCS session, participants will complete 20 minutes of cognitive training using a mobile application installed on an iPad. Cognitive testing will be conducted pre- and post-intervention using remote assessment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial Direct Current Stimulation (tDCS) | Device | transcranial Direct Current Stimulation (tDCS) involves modulation of cerebral cortex excitability by the application of weak direct current to the scalp. tDCS is a technique that applies safe, low level direct current through large pads on the scalp to stimulate the underlying brain region, with current level < 0.10 C/cm2. Direct current is transferred by a pair of saline-soaked sponges from the anode to the cathode. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of At Home tDCS Intervention | This outcome measures the feasibility of remote tDCS and cognitive training. The trial will be considered feasible if at least 50% of the survivors are able to complete 5 sessions (tDCS along with cognitive stimulation) successfully out of 10. | 5 weeks after participant enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Digit Span Forward | Digit Span Forward, Longest Digits Forward: 0-9; higher score indicates more digits recalled. Higher scores are better. | Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table. |
| Neurocognitive Questionnaire: CCSS-NCQ |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Krull, PhD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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Participants, care providers, investigator and outcomes assessor had no knowledge of group assignment.
During campus visit, participants received tDCS and sham sessions at day1 or day2 with only order changed due to randomization. A participant was considered as a control for him/herself. For At Home tDCS phase, single arm treatment was conducted.
Between March 2015 and April 2017, 53 participants were enrolled on study to complete one session of active tDCS and one session of sham tDCS. Participants must complete both to move to the At Home tDCS phase. Twenty participants were excluded due to screening failures.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | Participants completed tDCS set to sham, tDCS equipment set to active condition, then were to complete 10 stimulation sessions over 5 weeks using a mobile tDCS device twice per week. Within two hours of completing each tDCS session, participants were to complete 20 minutes of cognitive training using a mobile application installed on an iPad. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 8, 2015 |
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| Sham | Device | The sham intervention will be used in both arms with one arm receiving the sham intervention on day 1 and the other receiving the sham intervention on day 2. The sham procedure provides the same small current during ramp up to imitate the intervention, but the current is discontinued after ramp up and no intervention is provided. Direct current is transferred by a pair of saline-soaked sponges from the anode to the cathode. |
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| Cognitive Assessment | Other | Three tests will be used to evaluate cognitive function: Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, and List Sorting Working Memory Test. These measures have a computerized format and are nationally standardized. The Gray Oral Reading Test measures reading comprehension. Participants are asked to read a set of passages and recall specific details from the stories. The Woodcock Johnson Understanding Directions measures listening comprehension. Participants listen to a series of complex instructions, then follow the directions by pointing to various objects in a colored picture. |
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| Brain Games Stimulation | Other | Cognitive exercises using the Lumosity Brain Games program will be used simultaneously with the tDCS intervention. Participants will be asked to engage in training for 20 minutes a day, two days per week over 5 weeks. This program involves cognitive exercises designed to enhance executive function and processing speed. |
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The CCSS-NCQ is a 25 item self-report questionnaire to assess cognitive function across multiple domains in cancer survivors. Participant responses range from 1-3 for each item with higher score indicating more problems. Domain scores are created by summing the relevant item scores for each domain. Score ranges:
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| Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table. |
| NIH Toolbox Card Sort Task | The Card Sort Task measures cognitive flexibility and attention. Pictures are presented varying along two dimensions (e.g., shape and color). Participants must sort the pictures based on a given dimension. Scores range from 0-40 with higher scores indicating better function. | After active and sham interventions administered on day one and day two of the trial |
| NIH Toolbox Flanker Task | The Flanker Task measures attention and inhibitory control. Participant focuses on a given stimulus while inhibiting attention to stimuli flanking it. Scores range from 0-40 with higher scores indicating better function. | After active and sham interventions administered on day one and day two of the trial |
| NIH Toolbox Working Memory Function | The Working Memory Task measures working memory. Participant recalls and sequences different visually and orally presented stimuli. Scores range from 0-28 with higher scores indicating better working memory. | After active and sham interventions administered on day one and day two of the trial |
| Digit Span Backward | Digit Span Backward, Longest Digits Backward: 0-8; higher score indicates more digits recalled. Higher scores are better. | Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table. |
| Verbal Fluency | Verbal Fluency: minimum 0 with no maximum; Count of how many words were generated in 60 seconds per letter with three letters used with no top limit. Higher scores are better. | Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table. |
| Oral Trail Making Part A | Oral Trail Making Part A: minimum 0 with no maximum amount of time in seconds to say the given letters and numbers. Higher scores are worse. | Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table. |
| Oral Trail Making Part B | Oral Trail Making Part B: minimum 0 with no maximum amount of time in seconds to say the given letters and numbers. Higher scores are worse. | Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table. |
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Thirty one participants completed both the tDCS equipment set to sham condition and the tDCS equipment set to active condition. Two of the 33 participants who began the overall study did not complete the second day of the campus visit. Of the 31 who completed both days of the campus visit, 28 completed the at home portion.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | During campus visit, following randomized design each participant completed tDCS set to sham, tDCS equipment set to active condition, during two consecutive days. Participants who completed the campus visit session and evaluation then were to complete a single arm treatment of 10 stimulation sessions over 5 weeks using a mobile tDCS device twice per week. Within two hours of completing each tDCS session, participants were to complete 20 minutes of cognitive training using a mobile application installed on an iPad. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| 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 | Feasibility of At Home tDCS Intervention | This outcome measures the feasibility of remote tDCS and cognitive training. The trial will be considered feasible if at least 50% of the survivors are able to complete 5 sessions (tDCS along with cognitive stimulation) successfully out of 10. | Participant enrollment for At Home Feasibility of tDCS intervention n=28 Participants Analyzed (Week 5 reported n=25) | Posted | Count of Participants | Participants | No | 5 weeks after participant enrollment |
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| Secondary | Digit Span Forward | Digit Span Forward, Longest Digits Forward: 0-9; higher score indicates more digits recalled. Higher scores are better. | Posted | Mean | Standard Deviation | raw score | Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table. |
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| Secondary | Neurocognitive Questionnaire: CCSS-NCQ | The CCSS-NCQ is a 25 item self-report questionnaire to assess cognitive function across multiple domains in cancer survivors. Participant responses range from 1-3 for each item with higher score indicating more problems. Domain scores are created by summing the relevant item scores for each domain. Score ranges:
| Posted | Mean | Standard Deviation | scores on a scale | Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table. |
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| Secondary | NIH Toolbox Card Sort Task | The Card Sort Task measures cognitive flexibility and attention. Pictures are presented varying along two dimensions (e.g., shape and color). Participants must sort the pictures based on a given dimension. Scores range from 0-40 with higher scores indicating better function. | Posted | Mean | Standard Deviation | scores on a scale | After active and sham interventions administered on day one and day two of the trial |
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| Secondary | NIH Toolbox Flanker Task | The Flanker Task measures attention and inhibitory control. Participant focuses on a given stimulus while inhibiting attention to stimuli flanking it. Scores range from 0-40 with higher scores indicating better function. | Posted | Mean | Standard Deviation | scores on a scale | After active and sham interventions administered on day one and day two of the trial |
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| Secondary | NIH Toolbox Working Memory Function | The Working Memory Task measures working memory. Participant recalls and sequences different visually and orally presented stimuli. Scores range from 0-28 with higher scores indicating better working memory. | Posted | Mean | Standard Deviation | scores on a scale | After active and sham interventions administered on day one and day two of the trial |
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| Secondary | Digit Span Backward | Digit Span Backward, Longest Digits Backward: 0-8; higher score indicates more digits recalled. Higher scores are better. | Posted | Mean | Standard Deviation | raw score | Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table. |
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| Secondary | Verbal Fluency | Verbal Fluency: minimum 0 with no maximum; Count of how many words were generated in 60 seconds per letter with three letters used with no top limit. Higher scores are better. | Posted | Mean | Standard Deviation | raw score | Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table. |
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| Secondary | Oral Trail Making Part A | Oral Trail Making Part A: minimum 0 with no maximum amount of time in seconds to say the given letters and numbers. Higher scores are worse. | Posted | Mean | Standard Deviation | seconds | Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table. |
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| Secondary | Oral Trail Making Part B | Oral Trail Making Part B: minimum 0 with no maximum amount of time in seconds to say the given letters and numbers. Higher scores are worse. | Posted | Mean | Standard Deviation | seconds | Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table. |
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Adverse events were monitored before and after every tDCS session.
PRISE assesses presence of side effects for several biological systems. For each organ/function system, the participant indicates the presence of a side effect, and if present, the tolerability of the side effect (tolerable or distressing). FISER and GRSEB assess side effect impact: frequency, intensity, and burden. Each domain is rated on a 7- point Likert scale.
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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) |
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| EG000 | On Campus Sham tDCS | tDCS equipment set to sham condition. | 0 | 33 | 0 | 33 | 14 | 33 |
| EG001 | On Campus tDCS | tDCS equipment set to active condition. | 0 | 31 | 0 | 31 | 10 | 31 |
| EG002 | At Home tDCS | Participants completed 10 stimulation sessions over 5 weeks using a mobile tDCS device twice per week. Within two hours of completing each tDCS session, participants will complete 20 minutes of cognitive training using a mobile application installed on an iPad. | 0 | 28 | 0 | 28 | 25 | 28 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ringing in Ears | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
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| Headaches | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Fatigue/Restlessness | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Vivid Dreams/Nightmares | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Difficulty Sleeping | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Drowsiness During the Day | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Itching | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Dry Skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Krull, PhD | St. Jude Children's Research Hospital | (901) 595-5891 | kevin.krull@stjude.org |
| Apr 5, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D000073216 | Mental Status and Dementia Tests |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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