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CompletedNCT02300961Updated May 7, 2026

Feasibility Neurocognitive Outcome After Transplant

An interventional study of Cognitive rehabilitation program in Stem Cell Transplantation, Pediatric Cancer and Acute Lymphoblastic Leukemia, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 6 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-05-07.

Sponsored by Stanford University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
6 Years to 21 Years
Sex
All
01

Study summary

This pilot study will primarily be evaluated by feasibility and adherence to an iPad-based neurocognitive intervention program. It will secondarily be evaluated by performance on the neurocognitive testing post-transplant and change in performance in subsequent years.

02

Conditions studied

  • Stem Cell Transplantation
  • Pediatric Cancer
  • Acute Lymphoblastic Leukemia
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 17 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All patients must have a histologic or cytological diagnosis of ALL treated with stem cell transplantation. There are no restrictions on prior therapy.
  • Patients must be between the ages of 6 years and 21 years of age (inclusive), but there will be no discrimination based on gender, race, creed, or ethnic background. The age limits are set at 6 years of age in order to ensure that patients will be able to participate in these specific cognitive rehabilitation tasks. ECOG/KPS will not be employed.
  • Patient and/or parents/guardians as appropriate must sign an informed consent, be mentally responsible, able to understand and willing to sign a written informed consent.

Exclusion criteria

Exclusion Criteria:

  • Subjects with significant concurrent medical complications that in the judgment of the Principal Investigator(s) could affect the patient's ability to complete the planned trial. There are no therapy restrictions or restrictions regarding the use of other Investigational Agents.
  • Pregnant patients will be excluded.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    Cognitive rehabilitation arm

    Cognitive rehabilitation program

    Behavioral: Cognitive rehabilitation program

Interventions

  • BehavioralCognitive rehabilitation program
06

What researchers measure

Primary outcomes

  1. Number of participants who complete the post-transplant neurocognitive intervention program

    Number of participants who enroll in and are able to complete the neurocognitive intervention program, measured at 3 months after enrollment.

    Time frame: 3 months after enrollment

Secondary outcomes

  1. Number of participants who complete at least half of the neurocognitive intervention program

    Number of participants who complete at least 50% of scheduled sessions in the neurocognitive intervention program.

    Time frame: 3 months after enrollment

  2. Change in WISC-IV or WAIS-IV scores

    Change in intellectual functioning scores (Full Scale IQ, Verbal Comprehension, Perceptual Reasoning, Working Memory, and Processing Speed indices) from pre-treatment to 1 and 2 years post-treatment.

    Time frame: Baseline, 1 year post-treatment, 2 years post-treatment

  3. Change in WRAML-2 scores

    Change in verbal and visual memory scores from pre-treatment to 1 and 2 years post-treatment using the Wide Range Assessment of Memory and Learning, Second Edition (WRAML-2).

    Time frame: Baseline, 1 year post-treatment, 2 years post-treatment

  4. Change in executive functioning scores (D-KEFS or NEPSY-II)

    Change in executive functioning scores from pre-treatment to 1 and 2 years post-treatment, using Delis Kaplan Executive Function System (D-KEFS; ages 8-21) or NEPSY-II subtests (ages 6-7).

    Time frame: Baseline, 1 year post-treatment, 2 years post-treatment

  5. Change in CPT-II scores

    Change in sustained attention/vigilance scores from pre-treatment to 1 and 2 years post-treatment using Conners' Continuous Performance Test, Second Edition (CPT-II).

    Time frame: Baseline, 1 year post-treatment, 2 years post-treatment

07

Study locations

1 site
  • Stanford University, School of Medicine
    Palo Alto, California 94304, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02300961
Lead sponsor
Stanford University
Collaborators
Thrasher Research Fund
Responsible party
Sponsor
First posted
Nov 25, 2014
Start date
Dec 1, 2014
Primary completion
Feb 3, 2024
Completion
Feb 3, 2024
Last update
May 7, 2026

Study contacts

Susan Hiniker, MD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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