Cerebral Palsy (CP)NCT05071586
Pediatric Teleneuromodulation
A study testing Soterix 1x1 tDCS LTE Stimulator Device Model 1401 in people with Cerebral Palsy (CP), run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Soterix 1x1 tDCS LTE Stimulator Device Model 1401
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2022to 6 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Inaccessibility to internet and a working computer/laptop/device.
- Implants
- Neoplasm
- Metabolic Disorders
- Epilepsy
- Seizure within two years preceding the study
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remotely Monitored Transcranial Direct Current Stimulation in Children With Cerebral Palsy
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.
Read the 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.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Soterix 1x1 tDCS LTE Stimulator Device Model 1401
- Keywords
- Children with cerebral palsy, Remote transcranial direct current stimulation (tDCS), Non-invasive brain stimulation (NIBS)
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soterix 1x1 tDCS LTE Stimulator Device Model 1401Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Children diagnosed with stroke/brain bleed | Experimental | Male and females aged 8 to 21 with established diagnosis of stroke/brain bleed who are US residents. Receives: Device: Soterix 1x1 tDCS LTE Stimulator Device Model 1401 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Active Stimulation Sessions (20 min), 3 days total
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.
Measured: Post sessions on day 1, 2, 3, 4 , and 5
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
Measured: Average over 5 days
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
Measured: Post sessions on day 1, 2, 3, 4 , and 5
Secondary outcomes (2)
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.
Measured: Pre-stimulation on day 1, 2, 3, 4 and 5
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.
Measured: Post sessions on day 2, 3, 4 , and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start21 Dec 2022
- Primary completion6 Jun 2023
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernadette Gillick, PhD, MSPT, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071586
- Sponsor's protocol ID
- 2021-0691
- Other IDs
- Protocol ver 8 5/4/2023, Development Pediatrics
- Status last verified
- Apr 2024
- First submitted
- 13 Sep 2021
- Last updated
- 7 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lench DH, Simpson E, Sutter EN, Gillick BT. Feasibility of remote transcranial direct current stimulation for pediatric cerebral palsy during the COVID-19 pandemic. Brain Stimul. 2020 Nov-Dec;13(6):1803-1804. doi: 10.1016/j.brs.2020.10.010. Epub 2020 Oct 23. No abstract available.
PubMed 33132132Lench DH, Christopher P, Gavioli M, Nytes G, Ikonomidou C, Villegas MA, Gillick BT. Long-term outcome safety assessment after teleneuromodulation in children with cerebral palsy. Brain Stimul. 2024 May-Jun;17(3):633-635. doi: 10.1016/j.brs.2024.04.017. Epub 2024 May 11. No abstract available.
PubMed 38740181Christopher P, Sutter EN, Gavioli M, Lench DH, Nytes G, Mak V, Simpson EA, Ikonomidou C, Villegas MA, Saiote C, Gillick BT. Safety, tolerability and feasibility of remotely-instructed home-based transcranial direct current stimulation in children with cerebral palsy. Brain Stimul. 2023 Sep-Oct;16(5):1325-1327. doi: 10.1016/j.brs.2023.08.024. Epub 2023 Aug 29. No abstract available.
PubMed 37652136Simpson EA, Saiote C, Sutter E, Lench DH, Ikonomidou C, Villegas MA, Gillick BT. Remotely monitored transcranial direct current stimulation in pediatric cerebral palsy: open label trial protocol. BMC Pediatr. 2022 Sep 29;22(1):566. doi: 10.1186/s12887-022-03612-8.
PubMed 36175848
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remotely Monitored Transcranial Direct Current Stimulation in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05071586
- Acronym / sponsor ID
- 2021-0691
- Conditions
- Cerebral Palsy (CP)
- Keywords
- Children with cerebral palsy, Remote transcranial direct current stimulation (tDCS), Non-invasive brain stimulation (NIBS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 8 Oct 2021 (actual)
- Results
- Posted 7 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children diagnosed with stroke/brain bleed | Experimental | Device: Soterix 1x1 tDCS LTE Stimulator Device Model 1401Male and females aged 8 to 21 with established diagnosis of stroke/brain bleed who are US residents. |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (16 listed)
- Inaccessibility to internet and a working computer/laptop/device.
- Implants
- Neoplasm
- Metabolic Disorders
- Epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soterix 1x1 tDCS LTE Stimulator Device Model 1401Participants 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. | Device | Children diagnosed with stroke/brain bleed |
Primary outcome
Status/Safety Assessment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
2 secondary outcomes
Average Setup Time for Each Session
Time frame: Pre-stimulation on day 1, 2, 3, 4 and 5
Change in Box and Blocks Assessment Score
Time frame: Post sessions on day 2, 3, 4 , and 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33132132Lench DH, Simpson E, Sutter EN, Gillick BT. Feasibility of remote transcranial direct current stimulation for pediatric cerebral palsy during the COVID-19 pandemic. Brain Stimul. 2020 Nov-Dec;13(6):1803-1804. doi: 10.1016/j.brs.2020.10.010. Epub 2020 Oct 23. No abstract available.
- Derived from this study: PubMed 38740181Lench DH, Christopher P, Gavioli M, Nytes G, Ikonomidou C, Villegas MA, Gillick BT. Long-term outcome safety assessment after teleneuromodulation in children with cerebral palsy. Brain Stimul. 2024 May-Jun;17(3):633-635. doi: 10.1016/j.brs.2024.04.017. Epub 2024 May 11. No abstract available.
- Derived from this study: PubMed 37652136Christopher P, Sutter EN, Gavioli M, Lench DH, Nytes G, Mak V, Simpson EA, Ikonomidou C, Villegas MA, Saiote C, Gillick BT. Safety, tolerability and feasibility of remotely-instructed home-based transcranial direct current stimulation in children with cerebral palsy. Brain Stimul. 2023 Sep-Oct;16(5):1325-1327. doi: 10.1016/j.brs.2023.08.024. Epub 2023 Aug 29. No abstract available.
- Derived from this study: PubMed 36175848Simpson EA, Saiote C, Sutter E, Lench DH, Ikonomidou C, Villegas MA, Gillick BT. Remotely monitored transcranial direct current stimulation in pediatric cerebral palsy: open label trial protocol. BMC Pediatr. 2022 Sep 29;22(1):566. doi: 10.1186/s12887-022-03612-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernadette Gillick, PhD, MSPT principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soterix 1x1 tDCS LTE Stimulator Device Model 1401 in people with Cerebral Palsy (CP), run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Status/Safety Assessment (time frame: Active Stimulation Sessions (20 min), 3 days total). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05071586, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024; AzTrials last refreshed its copy on 27 Oct 2026.