Trial Outcomes & Findings for Treatment for Executive Dysfunction in Adult Survivors of Childhood Acute Lymphoblastic Leukemia (NCT NCT02336282)
NCT ID: NCT02336282
Last Updated: 2023-09-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
5 weeks after participant enrollment
Results posted on
2023-09-18
Participant Flow
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.
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.
Participant milestones
| Measure |
Overall Study
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.
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|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Overall Study
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.
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|---|---|
|
Overall Study
Unrelated illness
|
1
|
|
Overall Study
Uncomfortable with technology
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Not enough time to complete sessions
|
2
|
Baseline Characteristics
Treatment for Executive Dysfunction in Adult Survivors of Childhood Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Overall Study
n=31 Participants
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.
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|---|---|
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Age, Continuous
|
38.2 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 weeks after participant enrollmentPopulation: Participant enrollment for At Home Feasibility of tDCS intervention n=28 Participants Analyzed (Week 5 reported n=25)
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.
Outcome measures
| Measure |
At Home Feasibility of tDCS Intervention
n=28 Participants
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.
|
At Home tDCS - Follow-Up
Post- At Home tDCS session
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|---|---|---|
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Feasibility of At Home tDCS Intervention
|
25 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.Digit Span Forward, Longest Digits Forward: 0-9; higher score indicates more digits recalled. Higher scores are better.
Outcome measures
| Measure |
At Home Feasibility of tDCS Intervention
n=25 Participants
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.
|
At Home tDCS - Follow-Up
n=25 Participants
Post- At Home tDCS session
|
|---|---|---|
|
Digit Span Forward
|
5.7 raw score
Standard Deviation 1.0
|
5.7 raw score
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.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.
Outcome measures
| Measure |
At Home Feasibility of tDCS Intervention
n=25 Participants
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.
|
At Home tDCS - Follow-Up
n=25 Participants
Post- At Home tDCS session
|
|---|---|---|
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Neurocognitive Questionnaire: CCSS-NCQ
Organization
|
6.1 scores on a scale
Standard Deviation 1.7
|
5.7 scores on a scale
Standard Deviation 1.6
|
|
Neurocognitive Questionnaire: CCSS-NCQ
Emotional Regulation
|
5.9 scores on a scale
Standard Deviation 2.6
|
4.7 scores on a scale
Standard Deviation 1.6
|
|
Neurocognitive Questionnaire: CCSS-NCQ
Task Efficiency
|
17.5 scores on a scale
Standard Deviation 3.3
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16.2 scores on a scale
Standard Deviation 4.0
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|
Neurocognitive Questionnaire: CCSS-NCQ
Memory
|
8.1 scores on a scale
Standard Deviation 2.4
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8.3 scores on a scale
Standard Deviation 2.0
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SECONDARY outcome
Timeframe: After active and sham interventions administered on day one and day two of the trialThe 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.
Outcome measures
| Measure |
At Home Feasibility of tDCS Intervention
n=31 Participants
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.
|
At Home tDCS - Follow-Up
n=31 Participants
Post- At Home tDCS session
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|---|---|---|
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NIH Toolbox Card Sort Task
|
29.2 scores on a scale
Standard Deviation 0.6
|
29.1 scores on a scale
Standard Deviation 1.4
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SECONDARY outcome
Timeframe: After active and sham interventions administered on day one and day two of the trialThe 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.
Outcome measures
| Measure |
At Home Feasibility of tDCS Intervention
n=31 Participants
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.
|
At Home tDCS - Follow-Up
n=31 Participants
Post- At Home tDCS session
|
|---|---|---|
|
NIH Toolbox Flanker Task
|
19.9 scores on a scale
Standard Deviation 0.4
|
20.0 scores on a scale
Standard Deviation 0.0
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SECONDARY outcome
Timeframe: After active and sham interventions administered on day one and day two of the trialThe 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.
Outcome measures
| Measure |
At Home Feasibility of tDCS Intervention
n=31 Participants
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.
|
At Home tDCS - Follow-Up
n=31 Participants
Post- At Home tDCS session
|
|---|---|---|
|
NIH Toolbox Working Memory Function
|
17.0 scores on a scale
Standard Deviation 3.2
|
16.8 scores on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.Digit Span Backward, Longest Digits Backward: 0-8; higher score indicates more digits recalled. Higher scores are better.
Outcome measures
| Measure |
At Home Feasibility of tDCS Intervention
n=25 Participants
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.
|
At Home tDCS - Follow-Up
n=25 Participants
Post- At Home tDCS session
|
|---|---|---|
|
Digit Span Backward
|
3.7 raw score
Standard Deviation 1.0
|
4.2 raw score
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.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.
Outcome measures
| Measure |
At Home Feasibility of tDCS Intervention
n=25 Participants
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.
|
At Home tDCS - Follow-Up
n=25 Participants
Post- At Home tDCS session
|
|---|---|---|
|
Verbal Fluency
|
33.1 raw score
Standard Deviation 11.0
|
34.7 raw score
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.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.
Outcome measures
| Measure |
At Home Feasibility of tDCS Intervention
n=25 Participants
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.
|
At Home tDCS - Follow-Up
n=25 Participants
Post- At Home tDCS session
|
|---|---|---|
|
Oral Trail Making Part A
|
9.4 seconds
Standard Deviation 2.6
|
10.0 seconds
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.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.
Outcome measures
| Measure |
At Home Feasibility of tDCS Intervention
n=25 Participants
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.
|
At Home tDCS - Follow-Up
n=25 Participants
Post- At Home tDCS session
|
|---|---|---|
|
Oral Trail Making Part B
|
53.1 seconds
Standard Deviation 38.9
|
47.2 seconds
Standard Deviation 24.0
|
Adverse Events
On Campus Sham tDCS
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
On Campus tDCS
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
At Home tDCS
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
On Campus Sham tDCS
n=33 participants at risk
tDCS equipment set to sham condition.
|
On Campus tDCS
n=31 participants at risk
tDCS equipment set to active condition.
|
At Home tDCS
n=28 participants at risk
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.
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|---|---|---|---|
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Ear and labyrinth disorders
Ringing in Ears
|
0.00%
0/33 • Adverse events were monitored before and after every tDCS session.
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.
|
0.00%
0/31 • Adverse events were monitored before and after every tDCS session.
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.
|
14.3%
4/28 • Adverse events were monitored before and after every tDCS session.
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.
|
|
General disorders
Headaches
|
15.2%
5/33 • Adverse events were monitored before and after every tDCS session.
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.
|
3.2%
1/31 • Adverse events were monitored before and after every tDCS session.
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.
|
39.3%
11/28 • Adverse events were monitored before and after every tDCS session.
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.
|
|
General disorders
Fatigue/Restlessness
|
0.00%
0/33 • Adverse events were monitored before and after every tDCS session.
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.
|
3.2%
1/31 • Adverse events were monitored before and after every tDCS session.
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.
|
7.1%
2/28 • Adverse events were monitored before and after every tDCS session.
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.
|
|
Psychiatric disorders
Vivid Dreams/Nightmares
|
6.1%
2/33 • Adverse events were monitored before and after every tDCS session.
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.
|
6.5%
2/31 • Adverse events were monitored before and after every tDCS session.
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.
|
32.1%
9/28 • Adverse events were monitored before and after every tDCS session.
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.
|
|
Psychiatric disorders
Difficulty Sleeping
|
0.00%
0/33 • Adverse events were monitored before and after every tDCS session.
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.
|
3.2%
1/31 • Adverse events were monitored before and after every tDCS session.
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.
|
14.3%
4/28 • Adverse events were monitored before and after every tDCS session.
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.
|
|
Psychiatric disorders
Drowsiness During the Day
|
0.00%
0/33 • Adverse events were monitored before and after every tDCS session.
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.
|
3.2%
1/31 • Adverse events were monitored before and after every tDCS session.
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.
|
10.7%
3/28 • Adverse events were monitored before and after every tDCS session.
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.
|
|
Skin and subcutaneous tissue disorders
Itching
|
27.3%
9/33 • Adverse events were monitored before and after every tDCS session.
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.
|
25.8%
8/31 • Adverse events were monitored before and after every tDCS session.
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.
|
21.4%
6/28 • Adverse events were monitored before and after every tDCS session.
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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/33 • Adverse events were monitored before and after every tDCS session.
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.
|
3.2%
1/31 • Adverse events were monitored before and after every tDCS session.
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.
|
7.1%
2/28 • Adverse events were monitored before and after every tDCS session.
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.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/33 • Adverse events were monitored before and after every tDCS session.
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.
|
3.2%
1/31 • Adverse events were monitored before and after every tDCS session.
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.
|
7.1%
2/28 • Adverse events were monitored before and after every tDCS session.
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.
|
Additional Information
Kevin Krull, PhD
St. Jude Children's Research Hospital
Phone: (901) 595-5891
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place