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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months after participant enrollment

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am between 8 and 17 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor

428 Previous Clinical Trials

5,306,577 Total Patients Enrolled

Nicholas S Phillips, MD, PhDPrincipal InvestigatorSt. Jude Children's Research Hospital

Media Library

Anodal tDCS treatment (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04105530 — N/A

Acute Lymphoblastic Leukemia Research Study Groups: Transcranial direct current stimulation (tDCS) on day 2, Sham treatment, Transcranial direct current stimulation (tDCS) on day 1

Acute Lymphoblastic Leukemia Clinical Trial 2023: Anodal tDCS treatment Highlights & Side Effects. Trial Name: NCT04105530 — N/A

Anodal tDCS treatment (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04105530 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are taking part in this clinical investigation?

"Affirmative. Clinicaltrials.gov indicates that this medical trial, which was initially added on November 18th 2019, is recruiting participants at present. The research team hopes to enroll 30 patients from a single site."

Answered by AI

Is recruitment still taking place for this investigation?

"Affirmative. According to clinicaltrials.gov, this medical trial has been open for recruitment since its initial posting on November 18th 2019 and was last edited on October 3rd 2022. 30 participants are needed from 1 site in order to complete the study."

Answered by AI

Does the trial permit people aged fifty and above to participate?

"To be eligible to participate in this trial, potential enrollees must be between 8 and 215 months of age. It is also worth noting that there are 477 trials available for children under 18 years old and 1207 studies accessible to the elderly population over 65."

Answered by AI

Who meets the appropriate criteria to be an enrollee in this clinical trial?

"For this clinical trial, 30 participants aged 8 to 15 months who are suffering from acute lymphocytic leukemia and have a documented executive function, processing speed or memory impairment below the 10th percentile of their age-adjusted Z-score can apply."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transcranial Direct Current Stimulation of the Temporal Cortex in Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)

2019. "Transcranial Direct Current Stimulation of the Temporal Cortex in Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04105530.

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