Acute Lymphoblastic LeukemiaNCT04105530
Transcranial Direct Current Stimulation of the Temporal Cortex in Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)
A study testing Anodal tDCS treatment, Cathodal tDCS treatment and NIH Toolbox List Sorting Working Memory Test in people with Acute Lymphoblastic Leukemia and Transcranial Direct Current Stimulation, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
Brief Overview: Children and adolescents diagnosed with cancer will experience problems with learning, memory and attention during and after completing their cancer therapy. There are many factors that contribute to this problem, but investigators have recently identified that chemotherapy agents used in treating… Read more about this study
- Who is it for?
- Ages 8 years to 215 months
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Transcranial Direct Current Stimulation, Executive Dysfunction
- What is being tested?
- Anodal tDCS treatment, Cathodal tDCS treatment and NIH Toolbox List Sorting Working Memory Test
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2019to Sep 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 years to 215 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ALL survivors who received chemotherapy-only treatment and are enrolled in SJLIFE.
- 8-17 years old.
- History of executive function, processing speed and/or memory impairment documented as a score < 10th percentile of the age adjusted Z-score.
- Participants able to speak and understand the English language.
Who cannot join
- Survivors who received cranial radiation.
- Survivors with a Full-Scale IQ < 70.
- Pregnant, history of migraines, epilepsy or traumatic brain injury.
- Have a scalp or skin condition (e.g., psoriasis or eczema), metallic implants (except for dental fillings or caps) or retained metal fragments.
- History of neurologic condition or genetic disorder associated with neurocognitive impairment unrelated to cancer diagnosis or treatment.
- Not fluent in English.
- Taking a psychoactive drug or stimulant.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Brief Overview: Children and adolescents diagnosed with cancer will experience problems with learning, memory and attention during and after completing their cancer therapy. There are many factors that contribute to this problem, but investigators have recently identified that chemotherapy agents used in treating Acute Lymphoblastic Leukemia (ALL) may disrupt normal brain development.
A novel device has been developed that may help correct this disruption. Direct Current Stimulation (DCS) uses a very low level of constant electrical current to stimulate specific parts of the brain. It has been used in patients with stroke to great benefit. Our study at St. Jude Children's Research Hospital is designed to see if this technique will benefit survivors of childhood cancer. Specifically, investigators wish to see if stimulating one part of the brain gives a greater benefit than stimulating another part of the brain.
Read more
Primary Objective
Evaluate the feasibility of conducting repeated on-site Transcranial Direct Current Stimulation (tDCS) in children who are long-term survivors of
Secondary Objectives
- To estimate the potential efficacy for powering a future larger study using tDCS to improve cognitive performance in children by suppressing over connected neural hubs in long-term survivors of childhood ALL.
- To compare the performance of anodal stimulation of the frontal lobe to cathodal suppression of the superior temporal lobe on cognitive performance.
Read the detailed description
Participants will be randomly assigned to one of three intervention arms. Two brief stimulation periods will be conducted on day one. One brief stimulation will be scheduled in the morning and a second brief stimulation will be scheduled in the afternoon. A final stimulation will be conducted on day two. Direct Current Stimulation will be applied for 20 minutes for each stimulation period. Brief neurocognitive testing will be conducted during each stimulation session.
- Conditions
- Acute Lymphoblastic Leukemia, Transcranial Direct Current Stimulation, Executive Dysfunction
- Being tested
- Anodal tDCS treatment, Cathodal tDCS treatment, Sham treatment, NIH Toolbox List Sorting Working Memory Test, NIH Toolbox Flanker Inhibitory Control and Attention Test
- 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.
Anodal tDCS treatmentDevice
The Anodal intervention excites neuronal activity. For condition one, the anode will be attached to the left frontal region (Fp1) and the cathode will be attached to the right neck. The intervention involves a direct current of 1 mA applied for 20 minutes.
Cathodal tDCS treatmentDevice
The Cathodal intervention inhibits or reduces neuronal activity. We propose that the use of the cathodal tDCS to the superior temporal gyrus in survivors of childhood ALL may facilitate the inhibition of over connected motor-sensory and auditory neural networks. For condition two, the cathode will be attached to the left temporal region (T3) and the anode will be attached to the right neck. The intervention involves a direct current of 1 mA applied for 20 minutes.
Sham treatmentDevice
The sham procedure provides the same small current during ramp up to imitate the intervention, but the current is discontinued after ramping up and no intervention is provided. Sham will be applied for 20 minutes. Stimulation will start 5 minutes before testing and continue throughout completing the NIH Toolbox Cognitive Battery at each trial.
NIH Toolbox List Sorting Working Memory TestOther
List Sorting is using information processing and storage. Performance tends to peak in early adulthood and then decline across the life span. This task assesses working memory and requires the participant to sequence different visually- and orally-presented stimuli. The list scoring task takes approximately 7 minutes to administer. List Sorting is scored by summing the total number of items correctly recalled and sequenced on Lists-1 and -2, which can range from 0-26.
NIH Toolbox Flanker Inhibitory Control and Attention TestOther
The Flanker tests inhibitory control and attention and the capacity for new learning and information processing novel situations. This performance also reaches a peak in early adulthood and tends to decline across the life span. A total of 40 trials require 4 minutes. Scoring is based on both accuracy and reaction time, which will we evaluate individually as well as in combination. The raw scores are converted to a scale score with a mean of 100 and SD of 15. Higher scores indicate higher executive function.
Grooved Peg Board TestOther
The Grooved Peg Board test measures visual-motor coordination and motor speed. Additionally, it is cognitively challenging and has been associated with attention, perceptual speed and non-verbal reasoning. Performance is better in the dominant/preferred hand and tends to improve in childhood and decline with advancing age. The test consists of placing metal pegs with ridges along onside in matching slots as quickly as possible. The score is the time in seconds required to compete the array with each hand. Longer times reflect worse performance. Times are compared to normative data that is organized by ethnicity, age, gender and education. The test takes approximately 5 minutes to complete.
Buschke Selective Reminding TestOther
This selective reminding task purports to distinguish verbal memory into short-term and long-term components. Scores are organized by short- and long-term storage and retrieval with normative scores organized by age and gender. The task requires participants to remember a list of orally-presented words and recall them with selective reminders of the words that they didn't recall. The test will last 5-10 minutes and is available in four different versions, thus reducing rehearsal effects.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial direct current stimulation (tDCS) on day 1 | Active comparator | One stimulation will be conducted using Anodal treatment.
The Direct Current Anodal Stimulation will be applied for 20 minutes for each stimulation period. Brief neurocognitive testing will be conducted during each stimulation session. Receives: Device: Anodal tDCS treatment; Other: NIH Toolbox List Sorting Working Memory Test; Other: NIH Toolbox Flanker Inhibitory Control and Attention Test; Other: Grooved Peg Board Test; Other: Buschke Selective Reminding Test |
| Transcranial direct current stimulation (tDCS) on day 2 | Active comparator | A final stimulation will be conducted using Cathodal stimulation. Direct Current Cathodal Stimulation will be applied for 20 minutes for each stimulation period. Brief neurocognitive testing will be conducted during each stimulation session. Receives: Device: Cathodal tDCS treatment; Other: NIH Toolbox List Sorting Working Memory Test; Other: NIH Toolbox Flanker Inhibitory Control and Attention Test; Other: Grooved Peg Board Test; Other: Buschke Selective Reminding Test |
| Sham treatment | Placebo comparator | The sham procedure provides the same small current during ramp up to imitate the intervention, but the current is discontinued after ramping up and no intervention is provided. Sham will be applied for 20 minutes.Stimulation will start 5 minutes before testing and continue throughout completing the NIH Toolbox Cognitive Battery at each trial:" Receives: Device: Sham treatment; Other: NIH Toolbox List Sorting Working Memory Test; Other: NIH Toolbox Flanker Inhibitory Control and Attention Test; Other: Grooved Peg Board Test; Other: Buschke Selective Reminding Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who completed three sessions of tDC stimulation and cognitive testing.
The trial will be considered feasible if at least 30 survivors are able to complete 3 sessions (tDCS along with cognitive testing).
Measured: 12 months after participant enrollment
Secondary outcomes (4)
Bushke selective remining test (BSRT)
BSRT is a test that evaluates verbal memory performance
Measured: 48 hours
NIH toolbox list sorting working memory test (WM)
WM is a test that evaluates information processing and storage performance
Measured: 48 hours
NIH toolbox flanker inhibitory control and attention test (Flanker)
Flanker is a test that evaluates attention and inhibitory control
Measured: 48 hours
Grooved peg board test (GPB)
GPB is a test that evaluates visual-motor coordination and motor speed
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start18 Nov 2019
- Primary completion31 Dec 2023
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Enrollment is on hold per institutional COVID-19 guidelines
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas S Phillips, MD, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105530
- Sponsor's protocol ID
- ALLSUP
- Other IDs
- NCI-2019-07041
- Status last verified
- Jan 2024
- First submitted
- 25 Jun 2019
- Last updated
- 12 Jan 2024
- Results posted
- No
- 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 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation of the Temporal Cortex in Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)
- ClinicalTrials.gov ID
- NCT04105530
- Acronym / sponsor ID
- ALLSUP
- Conditions
- Acute Lymphoblastic Leukemia, Transcranial Direct Current Stimulation, Executive Dysfunction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- Sep 2024 (estimated)
- First posted
- 26 Sep 2019 (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.
Brief Overview: Children and adolescents diagnosed with cancer will experience problems with learning, memory and attention during and after completing their cancer therapy. There are many factors that contribute to this problem, but investigators have recently identified that chemotherapy agents used in treating Acute Lymphoblastic Leukemia (ALL) may disrupt normal brain development.
A novel device has been developed that may help correct this disruption. Direct Current Stimulation (DCS) uses a very low level of constant electrical current to stimulate specific parts of the brain. It has been used in patients with stroke to great benefit. Our study at St. Jude Children's Research Hospital is designed to see if this technique will benefit survivors of childhood cancer. Specifically, investigators wish to see if stimulating one part of the brain gives a greater benefit than stimulating another part of the brain.
Primary Objective
Evaluate the feasibility of conducting repeated on-site Transcranial Direct Current Stimulation (tDCS) in children who are long-term survivors of
Secondary Objectives
- To estimate the potential efficacy for powering a future larger study using tDCS to improve cognitive performance in children by suppressing over connected neural hubs in long-term survivors of childhood ALL.
- To compare the performance of anodal stimulation of the frontal lobe to cathodal suppression of the superior temporal lobe on cognitive performance.
Detailed description
Participants will be randomly assigned to one of three intervention arms. Two brief stimulation periods will be conducted on day one. One brief stimulation will be scheduled in the morning and a second brief stimulation will be scheduled in the afternoon. A final stimulation will be conducted on day two. Direct Current Stimulation will be applied for 20 minutes for each stimulation period. Brief neurocognitive testing will be conducted during each stimulation session.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Enrollment is on hold per institutional COVID-19 guidelines
| Arm | Type | Receives |
|---|---|---|
| Transcranial direct current stimulation (tDCS) on day 1 | Active comparator | Device: Anodal tDCS treatment, Other: NIH Toolbox List Sorting Working Memory Test, Other: NIH Toolbox Flanker Inhibitory Control and Attention Test, Other: Grooved Peg Board Test, Other: Buschke Selective Reminding TestOne stimulation will be conducted using Anodal treatment. The Direct Current Anodal Stimulation will be applied for 20 minutes for each stimulation period. Brief neurocognitive testing will be conducted during each stimulation session. |
| Transcranial direct current stimulation (tDCS) on day 2 | Active comparator | Device: Cathodal tDCS treatment, Other: NIH Toolbox List Sorting Working Memory Test, Other: NIH Toolbox Flanker Inhibitory Control and Attention Test, Other: Grooved Peg Board Test, Other: Buschke Selective Reminding TestA final stimulation will be conducted using Cathodal stimulation. Direct Current Cathodal Stimulation will be applied for 20 minutes for each stimulation period. Brief neurocognitive testing will be conducted during each stimulation session. |
| Sham treatment | Placebo comparator | Device: Sham treatment, Other: NIH Toolbox List Sorting Working Memory Test, Other: NIH Toolbox Flanker Inhibitory Control and Attention Test, Other: Grooved Peg Board Test, Other: Buschke Selective Reminding TestThe sham procedure provides the same small current during ramp up to imitate the intervention, but the current is discontinued after ramping up and no intervention is provided. Sham will be applied for 20 minutes.Stimulation will start 5 minutes before testing and continue throughout completing the NIH Toolbox Cognitive Battery at each trial:" |
Who may qualify
- Ages
- 8 years to 215 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- ALL survivors who received chemotherapy-only treatment and are enrolled in SJLIFE.
- 8-17 years old.
- History of executive function, processing speed and/or memory impairment documented as a score < 10th percentile of the age adjusted Z-score.
- Participants able to speak and understand the English language.
Key exclusion criteria (7 listed)
- Survivors who received cranial radiation.
- Survivors with a Full-Scale IQ < 70.
- Pregnant, history of migraines, epilepsy or traumatic brain injury.
- Have a scalp or skin condition (e.g., psoriasis or eczema), metallic implants (except for dental fillings or caps) or retained metal fragments.
- History of neurologic condition or genetic disorder associated with neurocognitive impairment unrelated to cancer diagnosis or treatment.
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 |
|---|---|---|
| Anodal tDCS treatmentThe Anodal intervention excites neuronal activity. For condition one, the anode will be attached to the left frontal region (Fp1) and the cathode will be attached to the right neck. The intervention involves a direct current of 1 mA applied for 20 minutes. | Device | Transcranial direct current stimulation (tDCS) on day 1 |
| Cathodal tDCS treatmentThe Cathodal intervention inhibits or reduces neuronal activity. We propose that the use of the cathodal tDCS to the superior temporal gyrus in survivors of childhood ALL may facilitate the inhibition of over connected motor-sensory and auditory neural networks. For condition two, the cathode will be attached to the left temporal region (T3) and the anode will be attached to the right neck. The intervention involves a direct current of 1 mA applied for 20 minutes. | Device | Transcranial direct current stimulation (tDCS) on day 2 |
| Sham treatmentThe sham procedure provides the same small current during ramp up to imitate the intervention, but the current is discontinued after ramping up and no intervention is provided. Sham will be applied for 20 minutes. Stimulation will start 5 minutes before testing and continue throughout completing the NIH Toolbox Cognitive Battery at each trial. | Device | Sham treatment |
| NIH Toolbox List Sorting Working Memory TestList Sorting is using information processing and storage. Performance tends to peak in early adulthood and then decline across the life span. This task assesses working memory and requires the participant to sequence different visually- and orally-presented stimuli. The list scoring task takes approximately 7 minutes to administer. List Sorting is scored by summing the total number of items correctly recalled and sequenced on Lists-1 and -2, which can range from 0-26. | Other | Sham treatment, Transcranial direct current stimulation (tDCS) on day 1, Transcranial direct current stimulation (tDCS) on day 2 |
| NIH Toolbox Flanker Inhibitory Control and Attention TestThe Flanker tests inhibitory control and attention and the capacity for new learning and information processing novel situations. This performance also reaches a peak in early adulthood and tends to decline across the life span. A total of 40 trials require 4 minutes. Scoring is based on both accuracy and reaction time, which will we evaluate individually as well as in combination. The raw scores are converted to a scale score with a mean of 100 and SD of 15. Higher scores indicate higher executive function. | Other | Sham treatment, Transcranial direct current stimulation (tDCS) on day 1, Transcranial direct current stimulation (tDCS) on day 2 |
| Grooved Peg Board TestThe Grooved Peg Board test measures visual-motor coordination and motor speed. Additionally, it is cognitively challenging and has been associated with attention, perceptual speed and non-verbal reasoning. Performance is better in the dominant/preferred hand and tends to improve in childhood and decline with advancing age. The test consists of placing metal pegs with ridges along onside in matching slots as quickly as possible. The score is the time in seconds required to compete the array with each hand. Longer times reflect worse performance. Times are compared to normative data that is organized by ethnicity, age, gender and education. The test takes approximately 5 minutes to complete. | Other | Sham treatment, Transcranial direct current stimulation (tDCS) on day 1, Transcranial direct current stimulation (tDCS) on day 2 |
| Buschke Selective Reminding TestThis selective reminding task purports to distinguish verbal memory into short-term and long-term components. Scores are organized by short- and long-term storage and retrieval with normative scores organized by age and gender. The task requires participants to remember a list of orally-presented words and recall them with selective reminders of the words that they didn't recall. The test will last 5-10 minutes and is available in four different versions, thus reducing rehearsal effects. | Other | Sham treatment, Transcranial direct current stimulation (tDCS) on day 1, Transcranial direct current stimulation (tDCS) on day 2 |
Primary outcome
Number of participants who completed three sessions of tDC stimulation and cognitive testing.
Time frame: 12 months after participant enrollment
The trial will be considered feasible if at least 30 survivors are able to complete 3 sessions (tDCS along with cognitive testing).
4 secondary outcomes
Bushke selective remining test (BSRT)
Time frame: 48 hours
NIH toolbox list sorting working memory test (WM)
Time frame: 48 hours
NIH toolbox flanker inhibitory control and attention test (Flanker)
Time frame: 48 hours
Grooved peg board test (GPB)
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- 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.
Nicholas S Phillips, MD, 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 Anodal tDCS treatment, Cathodal tDCS treatment and NIH Toolbox List Sorting Working Memory Test in people with Acute Lymphoblastic Leukemia and Transcranial Direct Current Stimulation, 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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 12 Jan 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of participants who completed three sessions of tDC stimulation and cognitive testing. (time frame: 12 months 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 12 Jan 2024.