Trial Outcomes & Findings for Pediatric Teleneuromodulation (NCT NCT05071586)
NCT ID: NCT05071586
Last Updated: 2024-05-07
Results Overview
Participants were asked to fill out an adverse event survey during active stimulation. Reported below are responses from the participants to the survey regardless of potential relation to stimulation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Active Stimulation Sessions (20 min), 3 days total
Results posted on
2024-05-07
Participant Flow
Participant milestones
| Measure |
Children Diagnosed With Stroke/Brain Bleed
Male and females aged 8 to 21 with established diagnosis of stroke/brain bleed who are US residents.
Soterix 1x1 tDCS LTE Stimulator Device Model 1401: Participants will receive 20 minutes of 1.5 mA (Milliampere) transcranial direct current stimulation (tDCS) via Soterix 1x1 tDCS LTE Stimulator Device Model 1401 with a bilateral M1 montage.
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pediatric Teleneuromodulation
Baseline characteristics by cohort
| Measure |
Children Diagnosed With Stroke/Brain Bleed
n=10 Participants
Male and females aged 8 to 21 with established diagnosis of stroke/brain bleed who are US residents.
Soterix 1x1 tDCS LTE Stimulator Device Model 1401: Participants will receive 20 minutes of 1.5 mA (Milliampere) transcranial direct current stimulation (tDCS) via Soterix 1x1 tDCS LTE Stimulator Device Model 1401 with a bilateral M1 montage.
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Age, Customized
10 years old
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1 Participants
n=5 Participants
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Age, Customized
13 years old
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2 Participants
n=5 Participants
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Age, Customized
15 years old
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1 Participants
n=5 Participants
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Age, Customized
16 years old
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4 Participants
n=5 Participants
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Age, Customized
18 years old
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1 Participants
n=5 Participants
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Age, Customized
19 years old
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1 Participants
n=5 Participants
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Sex: Female, Male
Female
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4 Participants
n=5 Participants
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Sex: Female, Male
Male
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6 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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9 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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8 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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10 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Active Stimulation Sessions (20 min), 3 days totalPopulation: Male and females aged 8 to 21 with established diagnosis of stroke/brain bleed who are US residents.
Participants were asked to fill out an adverse event survey during active stimulation. Reported below are responses from the participants to the survey regardless of potential relation to stimulation.
Outcome measures
| Measure |
Children Diagnosed With Stroke/Brain Bleed
n=30 Number of Sessions
Male and females aged 8 to 21 with established diagnosis of stroke/brain bleed who are US residents.
Soterix 1x1 tDCS LTE Stimulator Device Model 1401: Participants will receive 20 minutes of 1.5 mA (Milliampere) transcranial direct current stimulation (tDCS) via Soterix 1x1 tDCS LTE Stimulator Device Model 1401 with a bilateral M1 montage.
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Status/Safety Assessment
Sleepiness
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7 number of sessions symptom reported
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Status/Safety Assessment
Headache
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4 number of sessions symptom reported
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Status/Safety Assessment
Unusual Feelings on Skin of Head
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7 number of sessions symptom reported
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Status/Safety Assessment
Tingling
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20 number of sessions symptom reported
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Status/Safety Assessment
Itchiness
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12 number of sessions symptom reported
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Status/Safety Assessment
Difficulty paying attention
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2 number of sessions symptom reported
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Status/Safety Assessment
Unusual Emotions
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1 number of sessions symptom reported
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Status/Safety Assessment
Tooth Pain
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1 number of sessions symptom reported
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Status/Safety Assessment
Forgetfullness
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3 number of sessions symptom reported
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Status/Safety Assessment
Balance Issues
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3 number of sessions symptom reported
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Status/Safety Assessment
Abnormal sleep
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1 number of sessions symptom reported
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PRIMARY outcome
Timeframe: Post sessions on day 1, 2, 3, 4 , and 5To evaluate the quality of device setup, we will measure any changes or movement of the headgear. To do this, we will mark the starting and ending location of the headgear and measure the distance between the two. It will be reported if the headgear moved in any participants and the average displacement.
Outcome measures
| Measure |
Children Diagnosed With Stroke/Brain Bleed
n=50 Number of Sessions
Male and females aged 8 to 21 with established diagnosis of stroke/brain bleed who are US residents.
Soterix 1x1 tDCS LTE Stimulator Device Model 1401: Participants will receive 20 minutes of 1.5 mA (Milliampere) transcranial direct current stimulation (tDCS) via Soterix 1x1 tDCS LTE Stimulator Device Model 1401 with a bilateral M1 montage.
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Change in tDCS Headgear Location
Day 1
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0.9 avg movement distance in inches
Interval 0.5 to 2.0
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Change in tDCS Headgear Location
Day 2
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0.857 avg movement distance in inches
Interval 0.25 to 2.0
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Change in tDCS Headgear Location
Day 3
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1.125 avg movement distance in inches
Interval 0.25 to 2.0
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Change in tDCS Headgear Location
Day 4
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0.925 avg movement distance in inches
Interval 0.2 to 1.5
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Change in tDCS Headgear Location
Day 5
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0.675 avg movement distance in inches
Interval 0.2 to 1.0
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PRIMARY outcome
Timeframe: Average over 5 daysTo evaluate the feasibility of remotely monitored-tDCS, participants were asked how difficult the setup instructions were to understand on a 5 point scale (Very easy, easy, slightly difficult, very difficult, impossible). Set up instruction consisted of 6 steps, participants were asked to rate the steps each day. Results are reported as overall percentage of difficulty rating over 5 days
Outcome measures
| Measure |
Children Diagnosed With Stroke/Brain Bleed
n=300 Number of Responses
Male and females aged 8 to 21 with established diagnosis of stroke/brain bleed who are US residents.
Soterix 1x1 tDCS LTE Stimulator Device Model 1401: Participants will receive 20 minutes of 1.5 mA (Milliampere) transcranial direct current stimulation (tDCS) via Soterix 1x1 tDCS LTE Stimulator Device Model 1401 with a bilateral M1 montage.
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Step Difficulty Survey
Step 1: Very Easy
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84 percentage of responses
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Step Difficulty Survey
Step 1: Easy
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16 percentage of responses
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Step Difficulty Survey
Step 1: Neural
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0 percentage of responses
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Step Difficulty Survey
Step 1: Difficult
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0 percentage of responses
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Step Difficulty Survey
Step 1: Very Difficult
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0 percentage of responses
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Step Difficulty Survey
Step 2: Very Easy
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74 percentage of responses
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Step Difficulty Survey
Step2: Easy
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20 percentage of responses
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Step Difficulty Survey
Step 2: Neutral
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6 percentage of responses
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Step Difficulty Survey
Step 2: Difficult
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0 percentage of responses
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Step Difficulty Survey
Step 2: Very Difficult
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0 percentage of responses
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Step Difficulty Survey
Step 3: Very Easy
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72 percentage of responses
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Step Difficulty Survey
Step 3: Easy
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20 percentage of responses
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Step Difficulty Survey
Step 3: Neutral
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4 percentage of responses
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Step Difficulty Survey
Step 3: Difficult
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4 percentage of responses
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Step Difficulty Survey
Step 3: Very Difficult
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0 percentage of responses
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Step Difficulty Survey
Step 4: Very Easy
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94 percentage of responses
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Step Difficulty Survey
Step 4: Easy
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6 percentage of responses
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Step Difficulty Survey
Step 4: Neutral
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0 percentage of responses
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Step Difficulty Survey
Step 4: Difficult
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0 percentage of responses
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Step Difficulty Survey
Step 4: Very Diffucult
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0 percentage of responses
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Step Difficulty Survey
Step 5: Very Easy
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94 percentage of responses
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Step Difficulty Survey
Step 5: Easy
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6 percentage of responses
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Step Difficulty Survey
Step 5: Neutral
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0 percentage of responses
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Step Difficulty Survey
Step 5: Difficult
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0 percentage of responses
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Step Difficulty Survey
Step 5: Very Difficult
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0 percentage of responses
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Step Difficulty Survey
Step 6: Very Easy
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60 percentage of responses
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Step Difficulty Survey
Step 6: Easy
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32 percentage of responses
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Step Difficulty Survey
Step 6: Neutral
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2 percentage of responses
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Step Difficulty Survey
Step 6: Difficult
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6 percentage of responses
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Step Difficulty Survey
Step 6: Very Difficult
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0 percentage of responses
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PRIMARY outcome
Timeframe: Post sessions on day 1, 2, 3, 4 , and 5To evaluate the comfort of the device, participants will be asked how comfortable was wearing the headgear on a 4 point scale(Comfortable, Slightly uncomfortable, Uncomfortable but tolerable, Very uncomfortable, and I had to remove it) Result reported as total over the 5 day participation in study
Outcome measures
| Measure |
Children Diagnosed With Stroke/Brain Bleed
n=50 Number of Sessions
Male and females aged 8 to 21 with established diagnosis of stroke/brain bleed who are US residents.
Soterix 1x1 tDCS LTE Stimulator Device Model 1401: Participants will receive 20 minutes of 1.5 mA (Milliampere) transcranial direct current stimulation (tDCS) via Soterix 1x1 tDCS LTE Stimulator Device Model 1401 with a bilateral M1 montage.
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Responses to Comfort Survey
Day 1: Comfortable
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9 number of sessions when reported
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Responses to Comfort Survey
Day 1: Slightly uncomfortable
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1 number of sessions when reported
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Responses to Comfort Survey
Day 1: Uncomfortable but tolerable
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0 number of sessions when reported
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Responses to Comfort Survey
Day 1: Very uncomfortable, and I had to remove it
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0 number of sessions when reported
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Responses to Comfort Survey
Day 2: Comfortable
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8 number of sessions when reported
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Responses to Comfort Survey
Day 2: Slightly uncomfortable
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2 number of sessions when reported
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Responses to Comfort Survey
Day 2: Uncomfortable but tolerable
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0 number of sessions when reported
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Responses to Comfort Survey
Day 2: Very uncomfortable, and I had to remove it
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0 number of sessions when reported
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Responses to Comfort Survey
Day 3: Comfortable
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8 number of sessions when reported
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Responses to Comfort Survey
Day 3: Slightly Uncomfortable
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2 number of sessions when reported
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Responses to Comfort Survey
Day 3: Uncomfortable but tolerable
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0 number of sessions when reported
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Responses to Comfort Survey
Day 3: Very uncomfortable, and I had to remove it
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0 number of sessions when reported
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Responses to Comfort Survey
Day 4: Comfortable
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10 number of sessions when reported
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Responses to Comfort Survey
Day 4: Slightly Uncomfortable
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0 number of sessions when reported
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Responses to Comfort Survey
Day 4: Uncomfortable but tolerable
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0 number of sessions when reported
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Responses to Comfort Survey
Day 4: Very uncomfortable, and I had to remove it
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0 number of sessions when reported
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Responses to Comfort Survey
Day 5: Comfortable
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7 number of sessions when reported
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Responses to Comfort Survey
Day 5: Slightly Uncomfortable
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2 number of sessions when reported
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Responses to Comfort Survey
Day 5: Uncomfortable but tolerable
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1 number of sessions when reported
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Responses to Comfort Survey
Day 5: Very uncomfortable, and I had to remove it
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0 number of sessions when reported
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SECONDARY outcome
Timeframe: Pre-stimulation on day 1, 2, 3, 4 and 5To evaluate speed of device setup, time to complete montage set up will be measured and averaged among participants.
Outcome measures
| Measure |
Children Diagnosed With Stroke/Brain Bleed
n=10 Participants
Male and females aged 8 to 21 with established diagnosis of stroke/brain bleed who are US residents.
Soterix 1x1 tDCS LTE Stimulator Device Model 1401: Participants will receive 20 minutes of 1.5 mA (Milliampere) transcranial direct current stimulation (tDCS) via Soterix 1x1 tDCS LTE Stimulator Device Model 1401 with a bilateral M1 montage.
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Average Setup Time for Each Session
Day 1
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530 Time in seconds
Interval 312.0 to 691.0
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Average Setup Time for Each Session
Day 2
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566 Time in seconds
Interval 352.0 to 858.0
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Average Setup Time for Each Session
Day 3
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622 Time in seconds
Interval 360.0 to 1008.0
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Average Setup Time for Each Session
Day 4
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588 Time in seconds
Interval 239.0 to 1195.0
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Average Setup Time for Each Session
Day 5
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548 Time in seconds
Interval 249.0 to 1027.0
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SECONDARY outcome
Timeframe: Post sessions on day 2, 3, 4 , and 5To evaluate the potential change in motor function, the Box and Blocks score will be measured before and after each active session. This is a timed motor assessment, the score is the number of blocks successfully moved over a partition in one minute, a higher score indicates greater hand function. Lower scores indicate lower hand function. The reported outcome measure describes the change over each session in the Box and Blocks score. Motor function is not hypothesized to change due to the limited trials of active tDCS.
Outcome measures
| Measure |
Children Diagnosed With Stroke/Brain Bleed
n=40 number of sessions
Male and females aged 8 to 21 with established diagnosis of stroke/brain bleed who are US residents.
Soterix 1x1 tDCS LTE Stimulator Device Model 1401: Participants will receive 20 minutes of 1.5 mA (Milliampere) transcranial direct current stimulation (tDCS) via Soterix 1x1 tDCS LTE Stimulator Device Model 1401 with a bilateral M1 montage.
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Change in Box and Blocks Assessment Score
Session 2: dominant hand
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3 number of blocks moved
Standard Deviation 2.48
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Change in Box and Blocks Assessment Score
Session 2: non- dominant hand
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0 number of blocks moved
Standard Deviation 3.81
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Change in Box and Blocks Assessment Score
Session 3: dominant hand
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0.25 number of blocks moved
Standard Deviation 4.75
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Change in Box and Blocks Assessment Score
Session 3: non-dominant
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1.75 number of blocks moved
Standard Deviation 2.28
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Change in Box and Blocks Assessment Score
Session 4: dominant hand
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-0.75 number of blocks moved
Standard Deviation 4.70
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Change in Box and Blocks Assessment Score
Session 4: non-dominant hand
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-2 number of blocks moved
Standard Deviation 1.60
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Change in Box and Blocks Assessment Score
Session 5: dominant hand
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2.25 number of blocks moved
Standard Deviation 2.40
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Change in Box and Blocks Assessment Score
Session 5: non-dominant hand
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1.5 number of blocks moved
Standard Deviation 3.02
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Adverse Events
Children Diagnosed With Stroke/Brain Bleed
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Children Diagnosed With Stroke/Brain Bleed
n=10 participants at risk
Male and females aged 8 to 21 with established diagnosis of stroke/brain bleed who are US residents.
Soterix 1x1 tDCS LTE Stimulator Device Model 1401: Participants will receive 20 minutes of 1.5 mA (Milliampere) transcranial direct current stimulation (tDCS) via Soterix 1x1 tDCS LTE Stimulator Device Model 1401 with a bilateral M1 montage.
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General disorders
Headache
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40.0%
4/10 • Number of events 8 • The adverse event survey was collected each study sham and active study visit day (day 2, 3, 4,5) before stimulation, during simulation at the 10 minute mark, and post stimulation.
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General disorders
Unusual feelings on skin of head
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80.0%
8/10 • Number of events 8 • The adverse event survey was collected each study sham and active study visit day (day 2, 3, 4,5) before stimulation, during simulation at the 10 minute mark, and post stimulation.
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General disorders
Tingling
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90.0%
9/10 • Number of events 23 • The adverse event survey was collected each study sham and active study visit day (day 2, 3, 4,5) before stimulation, during simulation at the 10 minute mark, and post stimulation.
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General disorders
Itching
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60.0%
6/10 • Number of events 17 • The adverse event survey was collected each study sham and active study visit day (day 2, 3, 4,5) before stimulation, during simulation at the 10 minute mark, and post stimulation.
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General disorders
Sleepiness
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70.0%
7/10 • Number of events 14 • The adverse event survey was collected each study sham and active study visit day (day 2, 3, 4,5) before stimulation, during simulation at the 10 minute mark, and post stimulation.
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General disorders
Difficulty paying attention
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60.0%
6/10 • Number of events 8 • The adverse event survey was collected each study sham and active study visit day (day 2, 3, 4,5) before stimulation, during simulation at the 10 minute mark, and post stimulation.
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General disorders
Tooth pain
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10.0%
1/10 • Number of events 1 • The adverse event survey was collected each study sham and active study visit day (day 2, 3, 4,5) before stimulation, during simulation at the 10 minute mark, and post stimulation.
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General disorders
Dizziness
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10.0%
1/10 • Number of events 1 • The adverse event survey was collected each study sham and active study visit day (day 2, 3, 4,5) before stimulation, during simulation at the 10 minute mark, and post stimulation.
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Psychiatric disorders
Anxiety
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20.0%
2/10 • Number of events 3 • The adverse event survey was collected each study sham and active study visit day (day 2, 3, 4,5) before stimulation, during simulation at the 10 minute mark, and post stimulation.
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Psychiatric disorders
Forgetfulness
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10.0%
1/10 • Number of events 5 • The adverse event survey was collected each study sham and active study visit day (day 2, 3, 4,5) before stimulation, during simulation at the 10 minute mark, and post stimulation.
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General disorders
Balance
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10.0%
1/10 • Number of events 5 • The adverse event survey was collected each study sham and active study visit day (day 2, 3, 4,5) before stimulation, during simulation at the 10 minute mark, and post stimulation.
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General disorders
Abnormal sleep
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10.0%
1/10 • Number of events 1 • The adverse event survey was collected each study sham and active study visit day (day 2, 3, 4,5) before stimulation, during simulation at the 10 minute mark, and post stimulation.
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Psychiatric disorders
Unusual emotions
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10.0%
1/10 • Number of events 1 • The adverse event survey was collected each study sham and active study visit day (day 2, 3, 4,5) before stimulation, during simulation at the 10 minute mark, and post stimulation.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place