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Behavioural Intervention

tDCS for Childhood Leukemia Survivors

N/A

Waitlist Available

Led By Nicholas S Phillips, MD, PhD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

8-17 years old

Be younger than 18 years old

Must not have

Taking a psychoactive drug or stimulant

History of neurologic condition or genetic disorder associated with neurocognitive impairment unrelated to cancer diagnosis or treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months after participant enrollment

Summary

This trial will test whether a device that sends low levels of electrical current to the brain can help improve cognitive function in children who are long-term survivors of cancer.

Who is the study for?

This trial is for children aged 8-17 who survived childhood Acute Lymphoblastic Leukemia (ALL) and have learning, memory, or attention issues. They must have had chemotherapy but no cranial radiation, speak English, and not be on psychoactive drugs or stimulants.

What is being tested?

The study tests Transcranial Direct Current Stimulation (tDCS), a low-level electrical brain stimulation to improve cognitive function in ALL survivors. It compares the effects of stimulating different brain areas using various tDCS treatments versus sham treatment.

What are the potential side effects?

Potential side effects may include discomfort at the electrode sites on the scalp, itching or tingling during stimulation, fatigue, headache, nausea or dizziness. However, serious side effects are rare with tDCS.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 8 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking medication for my mental health.

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I have a neurological or genetic condition affecting my thinking or memory not related to my cancer.

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I am not fluent in English.

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I have received radiation therapy to my head.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months after participant enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months after participant enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months after participant enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants who completed three sessions of tDC stimulation and cognitive testing.

Secondary study objectives

Bushke selective remining test (BSRT)

Grooved peg board test (GPB)

NIH toolbox flanker inhibitory control and attention test (Flanker)

+1 more

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Transcranial direct current stimulation (tDCS) on day 2Active Control5 Interventions

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.

Group II: Transcranial direct current stimulation (tDCS) on day 1Active Control5 Interventions

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.

Group III: Sham treatmentPlacebo Group5 Interventions

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:"

0 / 5Eligibility criteria met