Acute Lymphoblastic LeukemiaNCT02336282
Treatment for Executive Dysfunction in Adult Survivors of Childhood Acute Lymphoblastic Leukemia
A study testing transcranial Direct Current Stimulation (tDCS), Cognitive Assessment and Brain Games Stimulation in people with Acute Lymphoblastic Leukemia, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- transcranial Direct Current Stimulation (tDCS), Cognitive Assessment and Brain Games Stimulation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2015to 20 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current St. Jude LIFE (SJLIFE) Protocol Participant
- Long term survivor of acute lymphoblastic leukemia (ALL)
- Currently ≥ 18 years of age
- Wi-Fi internet access at home
- History of executive dysfunction, documented by neurocognitive testing, and defined as having an age-adjusted standard score <20th percentile on Trail Making Test Part B, Verbal Fluency, or Digit Span Backward.
- History of self-reported executive dysfunction in daily life, defined as having a standardized score <20th percentile on BRIEF Initiate, Shift, or Working Memory domains OR having scored <20th percentile on the Childhood Cancer Survivor Study Neurocognitive Questionnaire Task Efficiency or Memory domains.
- Participant is able to speak and understand the English language.
Who cannot join
- Any survivor with full scale intelligence quotient (IQ) <80
- Currently on stimulants or other medications intended to treat cognitive impairment
- History of seizures
- No implanted medical devices or implanted metal in the head
- Currently pregnant or planning to become pregnant.
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: Feasibility and Efficacy of Transcranial Direct Current Stimulation (tDCS) and Cognitive Training for Executive Dysfunction in Adult Survivors of Childhood Acute Lymphoblastic Leukemia
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:
Read more
- To evaluate the feasibility of a home-based intervention using Transcranial Direct Current Stimulation (tDCS) and cognitive training in adult survivors of childhood ALL participating in the SJLIFE protocol at St. Jude Children's Research Hospital (SJCRH).
Secondary Objectives:
- To estimate the efficacy of a tDCS intervention paired with cognitive training.
- To explore the short-term effect of tDCS on measures of executive function among adult survivors of childhood ALL participating in the SJLIFE protocol
Read the detailed description
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.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- transcranial Direct Current Stimulation (tDCS), Sham, Cognitive Assessment, Brain Games Stimulation
- Keywords
- Adult survivor of acute lymphoblastic leukemia, Executive dysfunction, Transcranial direct current stimulation, Cancer prevention and control
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial Direct Current Stimulation (tDCS)Device
Also called tDCS, Transcranial Electrical Stimulation 1x1 Clinical Trials Device, Soterix Transcranial Direct Current Stimulator Clinical Trials, Soterix Medical Device 1x1-CT
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.
ShamDevice
Also called placebo
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.
Cognitive AssessmentOther
Also called NIH Toolbox Cognitive Battery, Gray Oral Reading Test, Woodcock Johnson Understanding Directions
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.
Brain Games StimulationOther
Also called Lumosity Brain Games, www.lumosity.com
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: transcranial Direct Current Stimulation (tDCS); Device: Sham; Other: Cognitive Assessment; Other: Brain Games Stimulation |
| 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. Receives: Device: transcranial Direct Current Stimulation (tDCS); Device: Sham; Other: Cognitive Assessment; Other: Brain Games Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks after participant enrollment
Secondary outcomes (9)
Digit Span Forward
Digit Span Forward, Longest Digits Forward: 0-9; higher score indicates more digits recalled. Higher scores are better.
Measured: 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
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:
- NCQ Task Efficiency: 9-27.
- NCQ Emotional Regulation: 3-9.
- NCQ Organization: 3-9.
- NCQ Memory: 4-12.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2015 (estimated)
- Study start12 Jan 2015
- Primary completion20 Jul 2017
- Study completion20 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Krull, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336282
- Sponsor's protocol ID
- ALLSTIM
- Other IDs
- NCI-2015-00050
- Status last verified
- Aug 2023
- First submitted
- 18 Dec 2014
- Last updated
- 18 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of Transcranial Direct Current Stimulation (tDCS) and Cognitive Training for Executive Dysfunction in Adult Survivors of Childhood Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT02336282
- Acronym / sponsor ID
- ALLSTIM
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Adult survivor of acute lymphoblastic leukemia, Executive dysfunction, Transcranial direct current stimulation, Cancer prevention and control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 12 Jan 2015 (actual)
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 20 Jul 2017 (actual)
- First posted
- 12 Jan 2015 (estimated)
- Results
- Posted 24 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the feasibility of a home-based intervention using Transcranial Direct Current Stimulation (tDCS) and cognitive training in adult survivors of childhood ALL participating in the SJLIFE protocol at St. Jude Children's Research Hospital (SJCRH).
Secondary Objectives:
- To estimate the efficacy of a tDCS intervention paired with cognitive training.
- To explore the short-term effect of tDCS on measures of executive function among adult survivors of childhood ALL participating in the SJLIFE protocol
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS on Day 1 | Active comparator | Device: transcranial Direct Current Stimulation (tDCS), Device: Sham, Other: Cognitive Assessment, Other: Brain Games StimulationOn 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. |
| tDCS on Day 2 | Active comparator | Device: transcranial Direct Current Stimulation (tDCS), Device: Sham, Other: Cognitive Assessment, Other: Brain Games StimulationOn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Current St. Jude LIFE (SJLIFE) Protocol Participant
- Long term survivor of acute lymphoblastic leukemia (ALL)
- Currently ≥ 18 years of age
- Wi-Fi internet access at home
- History of executive dysfunction, documented by neurocognitive testing, and defined as having an age-adjusted standard score <20th percentile on Trail Making Test Part B, Verbal Fluency, or Digit Span Backward.
Key exclusion criteria (6 listed)
- Any survivor with full scale intelligence quotient (IQ) <80
- Currently on stimulants or other medications intended to treat cognitive impairment
- History of seizures
- No implanted medical devices or implanted metal in the head
- Currently pregnant or planning to become pregnant.
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 |
|---|---|---|
| transcranial Direct Current Stimulation (tDCS)Also: tDCS, Transcranial Electrical Stimulation 1x1 Clinical Trials Device, Soterix Transcranial Direct Current Stimulator Clinical Trials, Soterix Medical Device 1x1-CTtranscranial 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. | Device | tDCS on Day 1, tDCS on Day 2 |
| ShamAlso: placeboThe 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. | Device | tDCS on Day 1, tDCS on Day 2 |
| Cognitive AssessmentAlso: NIH Toolbox Cognitive Battery, Gray Oral Reading Test, Woodcock Johnson Understanding DirectionsThree 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. | Other | tDCS on Day 1, tDCS on Day 2 |
| Brain Games StimulationAlso: Lumosity Brain Games, www.lumosity.comCognitive 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. | Other | tDCS on Day 1, tDCS on Day 2 |
Primary outcome
Feasibility of At Home tDCS Intervention
Time frame: 5 weeks after participant enrollment
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.
9 secondary outcomes
Digit Span Forward
Time frame: 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
Time frame: 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
Time frame: After active and sham interventions administered on day one and day two of the trial
NIH Toolbox Flanker Task
Time frame: After active and sham interventions administered on day one and day two of the trial
NIH Toolbox Working Memory Function
Time frame: After active and sham interventions administered on day one and day two of the trial
Digit Span Backward
Time frame: Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.
Verbal Fluency
Time frame: 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
Time frame: 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
Time frame: Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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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.
Kevin Krull, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial Direct Current Stimulation (tDCS), Cognitive Assessment and Brain Games Stimulation in people with Acute Lymphoblastic Leukemia, run by St. Jude Children's Research Hospital 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 7 inclusion and 6 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 18 Sep 2023. 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?
Yes. Results are posted in the registry (first posted 24 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility of At Home tDCS Intervention (time frame: 5 weeks after participant enrollment). 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 18 Sep 2023.