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Treatment for Executive Dysfunction in Adult Survivors of Childhood Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT02336282
Recruitment Status : Completed
First Posted : January 12, 2015
Results First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Acute Lymphoblastic Leukemia
Interventions Device: transcranial Direct Current Stimulation (tDCS)
Device: Sham
Other: Cognitive Assessment
Other: Brain Games Stimulation
Enrollment 53
Recruitment Details Between March 2015 and April 2017, 53 participants were enrolled on study to complete one session of active tDCS and one session of sham tDCS. Participants must complete both to move to the At Home tDCS phase. Twenty participants were excluded due to screening failures.
Pre-assignment Details

Participants, care providers, investigator and outcomes assessor had no knowledge of group assignment.

During campus visit, participants received tDCS and sham sessions at day1 or day2 with only order changed due to randomization. A participant was considered as a control for him/herself. For At Home tDCS phase, single arm treatment was conducted.

Arm/Group Title Overall Study
Hide Arm/Group Description Participants completed tDCS set to sham, tDCS equipment set to active condition, then were to complete 10 stimulation sessions over 5 weeks using a mobile tDCS device twice per week. Within two hours of completing each tDCS session, participants were to complete 20 minutes of cognitive training using a mobile application installed on an iPad.
Period Title: Overall Study
Started 33
Completed 28
Not Completed 5
Reason Not Completed
Unrelated illness             1
Uncomfortable with technology             1
Lost to Follow-up             1
Not enough time to complete sessions             2
Arm/Group Title Overall Study
Hide Arm/Group Description During campus visit, following randomized design each participant completed tDCS set to sham, tDCS equipment set to active condition, during two consecutive days. Participants who completed the campus visit session and evaluation then were to complete a single arm treatment of 10 stimulation sessions over 5 weeks using a mobile tDCS device twice per week. Within two hours of completing each tDCS session, participants were to complete 20 minutes of cognitive training using a mobile application installed on an iPad.
Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
Thirty one participants completed both the tDCS equipment set to sham condition and the tDCS equipment set to active condition. Two of the 33 participants who began the overall study did not complete the second day of the campus visit. Of the 31 who completed both days of the campus visit, 28 completed the at home portion.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants
38.2  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female 12
Male 19
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Hispanic or Latino 1
Not Hispanic or Latino 30
Unknown or Not Reported 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
American Indian or Alaska Native 0
Asian 0
Native Hawaiian or Other Pacific Islander 0
Black or African American 1
White 30
More than one race 0
Unknown or Not Reported 0
1.Primary Outcome
Title Feasibility of At Home tDCS Intervention
Hide Description This outcome measures the feasibility of remote tDCS and cognitive training. The trial will be considered feasible if at least 50% of the survivors are able to complete 5 sessions (tDCS along with cognitive stimulation) successfully out of 10.
Time Frame 5 weeks after participant enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Participant enrollment for At Home Feasibility of tDCS intervention n=28 Participants Analyzed (Week 5 reported n=25)
Arm/Group Title At Home Feasibility of tDCS Intervention
Hide Arm/Group Description:
All participants completed 10 stimulation sessions over 5 weeks using a mobile tDCS device twice per week. Within two hours of completing each tDCS session, participants will complete 20 minutes of cognitive training using a mobile application installed on an iPad.
Overall Number of Participants Analyzed 28
Measure Type: Count of Participants
Unit of Measure: Participants
25
2.Secondary Outcome
Title Digit Span Forward
Hide Description Digit Span Forward, Longest Digits Forward: 0-9; higher score indicates more digits recalled. Higher scores are better.
Time Frame Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title At Home tDCS - Baseline At Home tDCS - Follow-Up
Hide Arm/Group Description:
Pre- At Home tDCS session
Post- At Home tDCS session
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: raw score
5.7  (1.0) 5.7  (0.9)
3.Secondary Outcome
Title Neurocognitive Questionnaire: CCSS-NCQ
Hide Description

The CCSS-NCQ is a 25 item self-report questionnaire to assess cognitive function across multiple domains in cancer survivors. Participant responses range from 1-3 for each item with higher score indicating more problems. Domain scores are created by summing the relevant item scores for each domain. Score ranges:

  • NCQ Task Efficiency: 9-27.
  • NCQ Emotional Regulation: 3-9.
  • NCQ Organization: 3-9.
  • NCQ Memory: 4-12.
Time Frame Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title At Home tDCS - Baseline At Home tDCS - Follow-Up
Hide Arm/Group Description:
Participants completed NCQ questionnaire examiner read
Participants completed NCQ questionnaire examiner read
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Task Efficiency 17.5  (3.3) 16.2  (4.0)
Memory 8.1  (2.4) 8.3  (2.0)
Organization 6.1  (1.7) 5.7  (1.6)
Emotional Regulation 5.9  (2.6) 4.7  (1.6)
4.Secondary Outcome
Title NIH Toolbox Card Sort Task
Hide Description The Card Sort Task measures cognitive flexibility and attention. Pictures are presented varying along two dimensions (e.g., shape and color). Participants must sort the pictures based on a given dimension. Scores range from 0-40 with higher scores indicating better function.
Time Frame After active and sham interventions administered on day one and day two of the trial
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title On Campus Sham tDCS On Campus tDCS
Hide Arm/Group Description:
tDCS equipment set to sham condition.
tDCS equipment set to active condition.
Overall Number of Participants Analyzed 31 31
Mean (Standard Deviation)
Unit of Measure: scores on a scale
29.2  (0.6) 29.1  (1.4)
5.Secondary Outcome
Title NIH Toolbox Flanker Task
Hide Description The Flanker Task measures attention and inhibitory control. Participant focuses on a given stimulus while inhibiting attention to stimuli flanking it. Scores range from 0-40 with higher scores indicating better function.
Time Frame After active and sham interventions administered on day one and day two of the trial
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title On Campus Sham tDCS On Campus tDCS
Hide Arm/Group Description:
tDCS equipment set to sham condition.
tDCS equipment set to active condition.
Overall Number of Participants Analyzed 31 31
Mean (Standard Deviation)
Unit of Measure: scores on a scale
19.9  (0.4) 20.0  (0.0)
6.Secondary Outcome
Title NIH Toolbox Working Memory Function
Hide Description The Working Memory Task measures working memory. Participant recalls and sequences different visually and orally presented stimuli. Scores range from 0-28 with higher scores indicating better working memory.
Time Frame After active and sham interventions administered on day one and day two of the trial
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title On Campus Sham tDCS On Campus tDCS
Hide Arm/Group Description:
tDCS equipment set to sham condition.
tDCS equipment set to active condition.
Overall Number of Participants Analyzed 31 31
Mean (Standard Deviation)
Unit of Measure: scores on a scale
17.0  (3.2) 16.8  (2.9)
7.Secondary Outcome
Title Digit Span Backward
Hide Description Digit Span Backward, Longest Digits Backward: 0-8; higher score indicates more digits recalled. Higher scores are better.
Time Frame Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title At Home tDCS - Baseline At Home tDCS - Follow-Up
Hide Arm/Group Description:
Pre- At Home tDCS session
Post- At Home tDCS session
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: raw score
3.7  (1.0) 4.2  (1.0)
8.Secondary Outcome
Title Verbal Fluency
Hide Description Verbal Fluency: minimum 0 with no maximum; Count of how many words were generated in 60 seconds per letter with three letters used with no top limit. Higher scores are better.
Time Frame Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title At Home tDCS - Baseline At Home tDCS - Follow-Up
Hide Arm/Group Description:
Pre- At Home tDCS session
Post- At Home tDCS session
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: raw score
33.1  (11.0) 34.7  (12.0)
9.Secondary Outcome
Title Oral Trail Making Part A
Hide Description Oral Trail Making Part A: minimum 0 with no maximum amount of time in seconds to say the given letters and numbers. Higher scores are worse.
Time Frame Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title At Home tDCS - Baseline At Home tDCS - Follow-Up
Hide Arm/Group Description:
Pre- At Home tDCS session
Post- At Home tDCS session
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: seconds
9.4  (2.6) 10.0  (6.7)
10.Secondary Outcome
Title Oral Trail Making Part B
Hide Description Oral Trail Making Part B: minimum 0 with no maximum amount of time in seconds to say the given letters and numbers. Higher scores are worse.
Time Frame Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title At Home tDCS - Baseline At Home tDCS - Follow-Up
Hide Arm/Group Description:
Pre- At Home tDCS session
Post- At Home tDCS session
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: seconds
53.1  (38.9) 47.2  (24.0)
Time Frame Adverse events were monitored before and after every tDCS session.
Adverse Event Reporting Description PRISE assesses presence of side effects for several biological systems. For each organ/function system, the participant indicates the presence of a side effect, and if present, the tolerability of the side effect (tolerable or distressing). FISER and GRSEB assess side effect impact: frequency, intensity, and burden. Each domain is rated on a 7- point Likert scale.
 
Arm/Group Title On Campus Sham tDCS On Campus tDCS At Home tDCS
Hide Arm/Group Description tDCS equipment set to sham condition. tDCS equipment set to active condition. Participants completed 10 stimulation sessions over 5 weeks using a mobile tDCS device twice per week. Within two hours of completing each tDCS session, participants will complete 20 minutes of cognitive training using a mobile application installed on an iPad.
All-Cause Mortality
On Campus Sham tDCS On Campus tDCS At Home tDCS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/31 (0.00%)   0/28 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
On Campus Sham tDCS On Campus tDCS At Home tDCS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/31 (0.00%)   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
On Campus Sham tDCS On Campus tDCS At Home tDCS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/33 (42.42%)   10/31 (32.26%)   25/28 (89.29%) 
Ear and labyrinth disorders       
Ringing in Ears  1  0/33 (0.00%)  0/31 (0.00%)  4/28 (14.29%) 
General disorders       
Headaches  1  5/33 (15.15%)  1/31 (3.23%)  11/28 (39.29%) 
Fatigue/Restlessness  1  0/33 (0.00%)  1/31 (3.23%)  2/28 (7.14%) 
Psychiatric disorders       
Vivid Dreams/Nightmares  1  2/33 (6.06%)  2/31 (6.45%)  9/28 (32.14%) 
Difficulty Sleeping  1  0/33 (0.00%)  1/31 (3.23%)  4/28 (14.29%) 
Drowsiness During the Day  1  0/33 (0.00%)  1/31 (3.23%)  3/28 (10.71%) 
Skin and subcutaneous tissue disorders       
Itching  1  9/33 (27.27%)  8/31 (25.81%)  6/28 (21.43%) 
Rash  1  0/33 (0.00%)  1/31 (3.23%)  2/28 (7.14%) 
Dry Skin  1  0/33 (0.00%)  1/31 (3.23%)  2/28 (7.14%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Kevin Krull, PhD
Organization: St. Jude Children's Research Hospital
Phone: (901) 595-5891
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT02336282     History of Changes
Other Study ID Numbers: ALLSTIM
NCI-2015-00050 ( Registry Identifier: NCI Clinical Trial Registration Program )
First Submitted: December 18, 2014
First Posted: January 12, 2015
Results First Submitted: April 5, 2018
Results First Posted: August 24, 2018
Last Update Posted: August 24, 2018