Cerebral Palsy (CP)
Conditions
Keywords
Children with cerebral palsy, Remote transcranial direct current stimulation (tDCS), Non-invasive brain stimulation (NIBS)
Brief summary
This study will explore using remotely monitored 'active' non-invasive brain stimulation in children with cerebral palsy. Participants will receive active non-invasive brain stimulation with synchronous safety monitoring and guided instruction with laboratory staff after appropriate training. Participants will be between 8-21 years old and have a diagnosis of hemiparetic cerebral palsy with a history of a perinatal stroke or brain bleed, and can expect to be in the study for 5 days.
Detailed description
Current exploratory single site open label unblinded trial, will assess the feasibility, tolerability, and safety of active tDCS in the home setting under caregiver, safety monitor and remote investigator supervision and direction. The study population will consist of 10 participants between ages 8 - 21 years and 365 days with hemiparetic cerebral palsy and a history of a brain bleed or stroke. An estimated 3.6 per 1,000 births in the United States are affected by stroke or brain bleeds which can lead to Cerebral Palsy (CP), a developmental disorder associated with motor impairment. While, the majority of rehabilitation approaches focus on behavioral repetition to improve gait and upper extremity function, these therapies can require extensive practice times and extent of recovery is variable. Thus, there is a need for novel strategies which can optimize rehabilitation outcomes for this population. Brain development during childhood is characterized by heighted neuroplastic potential stressing the importance for intervention methods that harness neuroplasticity. Accordingly, several therapies are theoretically based in mechanisms of motor learning and use-dependent plasticity. Non-invasive brain stimulation (NIBS), specifically transcranial direct current stimulation (tDCS), provides an approach for modulation of neuroplasticity that is safe, inexpensive, and portable. Furthermore, rehabilitation approaches combined with tDCS have shown promise to improve motor function recovery and quality of life after stroke in adults. Integrating the application of NIBS may allow for enhanced rehabilitation during the enhanced neuroplastic period of childhood and NIBS has demonstrated promising outcomes in increasing the rate and extent of recovery. The Pediatric Neuromodulation laboratory has shown that in children with CP the use of tDCS is safe, feasible, and successful at modifying motor performance when in combination with other physical therapy interventions. tDCS is not currently available to subjects without taking part in the study. In this study, investigators plan to administer tDCS in the remote setting during a synchronous zoom call with trained laboratory members. To ensure the device is safely used in the home setting only during designated times, in the presence of a trained safety monitor. The safety monitor will bring the device to the session, oversee the safety of its use, and take it back to the laboratory after the session is complete. This intervention has the potential to improve motor rehabilitation outcomes and can offer telehealth access, which may reduce treatment cost and improve access to limited access to clinic or hospital facilities. This study has the potential to set the foundation for larger clinical trials studies evaluating the efficacy of remote tDCS combined with rehabilitation interventions in children. Ultimately, this will contribute to a wider reach in improving quality of life across the lifespan in children with CP. On Day #1 there will be a practice stimulation montage setup assessment. Before their session, a GMFCS and pediatric cognition survey will be completed with the investigative team. All participants will be asked to view instructional videos on how to perform the procedures. Parent/child pairs will perform the assessment by walking through the steps with the guidance of the lab team member via videoconferencing. Efficiency and quality of setup data will be collected. A setup ease/comfort survey will be completed upon completion of the stimulation montage setup. Days 2-5 will consist of sham/active stimulation in the home setting under caregiver, safety monitor, and remote investigator supervision and direction. Status surveys inquiring well-being will be conducted before, during, and after stimulation as well as a Box and Blocks motor function tests. At any time the participant perceives discomfort while dosing to 1.5mA the investigators will adapt and modify the stimulation intensity. Protocol Amendment Approved 6/7/2023: addition of an optional 6 and 12 month study visit.
Interventions
DEVICESoterix 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.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 8 years 0 days and 21 years 365 days * Children who have hemiparetic cerebral palsy with a history of perinatal brain bleed/stroke * Receptive language function to follow two-step commands * Able to give informed assent along with the informed consent of the legal guardian. If the participant is 18-21 (with the capacity to consent), they must be able to give informed consent. * Intentional about representing the sub-population of children with CP who experience intellectual disability (at least 2/10 participants with mild intellectual disabilities will be recruited) * ≥ 10 degrees of active motion at the metacarpophalangeal joint * Children who have had surgeries, which may influence motor function e.g.- tendon transfer, will be included, yet surgical history will be documented and included in any publication within a participant characteristics table.
Exclusion criteria
* Inaccessibility to internet and a working computer/laptop/device. * Implants * Neoplasm * Metabolic Disorders * Epilepsy * Seizure within two years preceding the study * Acquired Traumatic Brain Injury * Pregnancy * Indwelling metal or incompatible medical devices * Evidence of skin disease or skin abnormalities * Botulinum toxin or Phenol block within \[six-months\] preceding the study * Disorder of Cellular Migration and Proliferation To be eligible for the optional 6-month/12-month follow-up: * participants must have previously participated in the primary study * have access to a reliable internet connection and a functioning computer, laptop, or mobile device. * If participants become pregnant after participating in primary study, they may participate in the 6- and 12-month follow up sessions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Status/Safety Assessment | Active Stimulation Sessions (20 min), 3 days total | 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. |
| Change in tDCS Headgear Location | Post sessions on day 1, 2, 3, 4 , and 5 | To 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. |
| Step Difficulty Survey | Average over 5 days | To 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 |
| Responses to Comfort Survey | Post sessions on day 1, 2, 3, 4 , and 5 | To 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Setup Time for Each Session | Pre-stimulation on day 1, 2, 3, 4 and 5 | To evaluate speed of device setup, time to complete montage set up will be measured and averaged among participants. |
| Change in Box and Blocks Assessment Score | Post sessions on day 2, 3, 4 , and 5 | To 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Children Diagnosed With Stroke/Brain Bleed |
|---|---|
| Age, Customized 10 years old | 1 Participants |
| Age, Customized 13 years old | 2 Participants |
| Age, Customized 15 years old | 1 Participants |
| Age, Customized 16 years old | 4 Participants |
| Age, Customized 18 years old | 1 Participants |
| Age, Customized 19 years old | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 10 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Change in tDCS Headgear Location
To 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.
Time frame: Post sessions on day 1, 2, 3, 4 , and 5
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Children Diagnosed With Stroke/Brain Bleed | Change in tDCS Headgear Location | Day 1 | 0.9 avg movement distance in inches |
| Children Diagnosed With Stroke/Brain Bleed | Change in tDCS Headgear Location | Day 2 | 0.857 avg movement distance in inches |
| Children Diagnosed With Stroke/Brain Bleed | Change in tDCS Headgear Location | Day 3 | 1.125 avg movement distance in inches |
| Children Diagnosed With Stroke/Brain Bleed | Change in tDCS Headgear Location | Day 4 | 0.925 avg movement distance in inches |
| Children Diagnosed With Stroke/Brain Bleed | Change in tDCS Headgear Location | Day 5 | 0.675 avg movement distance in inches |
Primary
Responses to Comfort Survey
To 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
Time frame: Post sessions on day 1, 2, 3, 4 , and 5
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Children Diagnosed With Stroke/Brain Bleed | Responses to Comfort Survey | Day 1: Comfortable | 9 number of sessions when reported |
| Children Diagnosed With Stroke/Brain Bleed | Responses to Comfort Survey | Day 1: Slightly uncomfortable | 1 number of sessions when reported |
| Children Diagnosed With Stroke/Brain Bleed | Responses to Comfort Survey | Day 1: Uncomfortable but tolerable | 0 number of sessions when reported |
| Children Diagnosed With Stroke/Brain Bleed | Responses to Comfort Survey | Day 1: Very uncomfortable, and I had to remove it | 0 number of sessions when reported |
| Children Diagnosed With Stroke/Brain Bleed | Responses to Comfort Survey | Day 2: Comfortable | 8 number of sessions when reported |
| Children Diagnosed With Stroke/Brain Bleed | Responses to Comfort Survey | Day 2: Slightly uncomfortable | 2 number of sessions when reported |
| Children Diagnosed With Stroke/Brain Bleed | Responses to Comfort Survey | Day 2: Uncomfortable but tolerable | 0 number of sessions when reported |
| Children Diagnosed With Stroke/Brain Bleed | Responses to Comfort Survey | Day 2: Very uncomfortable, and I had to remove it | 0 number of sessions when reported |
| Children Diagnosed With Stroke/Brain Bleed | Responses to Comfort Survey | Day 3: Comfortable | 8 number of sessions when reported |
| Children Diagnosed With Stroke/Brain Bleed | Responses to Comfort Survey | Day 3: Slightly Uncomfortable | 2 number of sessions when reported |
| Children Diagnosed With Stroke/Brain Bleed | Responses to Comfort Survey | Day 3: Uncomfortable but tolerable | 0 number of sessions when reported |
| Children Diagnosed With Stroke/Brain Bleed | Responses to Comfort Survey | Day 3: Very uncomfortable, and I had to remove it | 0 number of sessions when reported |
| Children Diagnosed With Stroke/Brain Bleed | Responses to Comfort Survey | Day 4: Comfortable | 10 number of sessions when reported |
| Children Diagnosed With Stroke/Brain Bleed | Responses to Comfort Survey | Day 4: Slightly Uncomfortable | 0 number of sessions when reported |
| Children Diagnosed With Stroke/Brain Bleed | Responses to Comfort Survey | Day 4: Uncomfortable but tolerable | 0 number of sessions when reported |
| Children Diagnosed With Stroke/Brain Bleed | Responses to Comfort Survey | Day 4: Very uncomfortable, and I had to remove it | 0 number of sessions when reported |
| Children Diagnosed With Stroke/Brain Bleed | Responses to Comfort Survey | Day 5: Comfortable | 7 number of sessions when reported |
| Children Diagnosed With Stroke/Brain Bleed | Responses to Comfort Survey | Day 5: Slightly Uncomfortable | 2 number of sessions when reported |
| Children Diagnosed With Stroke/Brain Bleed | Responses to Comfort Survey | Day 5: Uncomfortable but tolerable | 1 number of sessions when reported |
| Children Diagnosed With Stroke/Brain Bleed | Responses to Comfort Survey | Day 5: Very uncomfortable, and I had to remove it | 0 number of sessions when reported |
Primary
Status/Safety Assessment
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.
Time frame: Active Stimulation Sessions (20 min), 3 days total
Population: Male and females aged 8 to 21 with established diagnosis of stroke/brain bleed who are US residents.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Children Diagnosed With Stroke/Brain Bleed | Status/Safety Assessment | Unusual Feelings on Skin of Head | 7 number of sessions symptom reported |
| Children Diagnosed With Stroke/Brain Bleed | Status/Safety Assessment | Headache | 4 number of sessions symptom reported |
| Children Diagnosed With Stroke/Brain Bleed | Status/Safety Assessment | Tingling | 20 number of sessions symptom reported |
| Children Diagnosed With Stroke/Brain Bleed | Status/Safety Assessment | Itchiness | 12 number of sessions symptom reported |
| Children Diagnosed With Stroke/Brain Bleed | Status/Safety Assessment | Sleepiness | 7 number of sessions symptom reported |
| Children Diagnosed With Stroke/Brain Bleed | Status/Safety Assessment | Difficulty paying attention | 2 number of sessions symptom reported |
| Children Diagnosed With Stroke/Brain Bleed | Status/Safety Assessment | Unusual Emotions | 1 number of sessions symptom reported |
| Children Diagnosed With Stroke/Brain Bleed | Status/Safety Assessment | Tooth Pain | 1 number of sessions symptom reported |
| Children Diagnosed With Stroke/Brain Bleed | Status/Safety Assessment | Forgetfullness | 3 number of sessions symptom reported |
| Children Diagnosed With Stroke/Brain Bleed | Status/Safety Assessment | Balance Issues | 3 number of sessions symptom reported |
| Children Diagnosed With Stroke/Brain Bleed | Status/Safety Assessment | Abnormal sleep | 1 number of sessions symptom reported |
Primary
Step Difficulty Survey
To 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
Time frame: Average over 5 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 1: Very Easy | 84 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 1: Easy | 16 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 1: Neural | 0 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 1: Difficult | 0 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 1: Very Difficult | 0 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 2: Very Easy | 74 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step2: Easy | 20 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 2: Neutral | 6 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 2: Difficult | 0 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 2: Very Difficult | 0 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 3: Very Easy | 72 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 3: Easy | 20 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 3: Neutral | 4 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 3: Difficult | 4 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 3: Very Difficult | 0 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 4: Very Easy | 94 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 4: Easy | 6 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 4: Neutral | 0 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 4: Difficult | 0 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 4: Very Diffucult | 0 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 5: Very Easy | 94 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 5: Easy | 6 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 5: Neutral | 0 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 5: Difficult | 0 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 5: Very Difficult | 0 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 6: Very Easy | 60 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 6: Easy | 32 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 6: Neutral | 2 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 6: Difficult | 6 percentage of responses |
| Children Diagnosed With Stroke/Brain Bleed | Step Difficulty Survey | Step 6: Very Difficult | 0 percentage of responses |
Secondary
Average Setup Time for Each Session
To evaluate speed of device setup, time to complete montage set up will be measured and averaged among participants.
Time frame: Pre-stimulation on day 1, 2, 3, 4 and 5
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Children Diagnosed With Stroke/Brain Bleed | Average Setup Time for Each Session | Day 1 | 530 Time in seconds |
| Children Diagnosed With Stroke/Brain Bleed | Average Setup Time for Each Session | Day 2 | 566 Time in seconds |
| Children Diagnosed With Stroke/Brain Bleed | Average Setup Time for Each Session | Day 3 | 622 Time in seconds |
| Children Diagnosed With Stroke/Brain Bleed | Average Setup Time for Each Session | Day 4 | 588 Time in seconds |
| Children Diagnosed With Stroke/Brain Bleed | Average Setup Time for Each Session | Day 5 | 548 Time in seconds |
Secondary
Change in Box and Blocks Assessment Score
To 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.
Time frame: Post sessions on day 2, 3, 4 , and 5
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Children Diagnosed With Stroke/Brain Bleed | Change in Box and Blocks Assessment Score | Session 2: dominant hand | 3 number of blocks moved | Standard Deviation 2.48 |
| Children Diagnosed With Stroke/Brain Bleed | Change in Box and Blocks Assessment Score | Session 2: non- dominant hand | 0 number of blocks moved | Standard Deviation 3.81 |
| Children Diagnosed With Stroke/Brain Bleed | Change in Box and Blocks Assessment Score | Session 3: dominant hand | 0.25 number of blocks moved | Standard Deviation 4.75 |
| Children Diagnosed With Stroke/Brain Bleed | Change in Box and Blocks Assessment Score | Session 3: non-dominant | 1.75 number of blocks moved | Standard Deviation 2.28 |
| Children Diagnosed With Stroke/Brain Bleed | Change in Box and Blocks Assessment Score | Session 4: dominant hand | -0.75 number of blocks moved | Standard Deviation 4.7 |
| Children Diagnosed With Stroke/Brain Bleed | Change in Box and Blocks Assessment Score | Session 4: non-dominant hand | -2 number of blocks moved | Standard Deviation 1.6 |
| Children Diagnosed With Stroke/Brain Bleed | Change in Box and Blocks Assessment Score | Session 5: dominant hand | 2.25 number of blocks moved | Standard Deviation 2.4 |
| Children Diagnosed With Stroke/Brain Bleed | Change in Box and Blocks Assessment Score | Session 5: non-dominant hand | 1.5 number of blocks moved | Standard Deviation 3.02 |