NCT04105530Active, not recruiting
Transcranial Direct Current Stimulation of the Temporal Cortex in Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)
Source: ClinicalTrials.gov · Last updated 12 Jan 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 25 Jun 2019
- Start date
- 18 Nov 2019
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- St. Jude Children's Research Hospital
- NCT number
- NCT04105530
What you commit to
- Study type: Interventional
- Planned participants: 36
- From 18 Nov 2019 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Survivors who received cranial radiation.
- Taking a psychoactive drug or stimulant.
Other illness
- 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.
Other
- Survivors with a Full-Scale IQ \< 70.
- Not fluent in English.
Who the study is looking for
- 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.
Age in the registry: 8 years to 215 months · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.