Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001065684
Ethics application status
Approved
Date submitted
22/08/2023
Date registered
4/10/2023
Date last updated
15/09/2024
Date data sharing statement initially provided
4/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Non-Invasive Brain Stimulation for Children and Young People with Cerebral Palsy
Scientific title
Safety and Feasibility of Remotely Monitored Transcranial Direct Current Stimulation in Children with Cerebral Palsy
Secondary ID [1] 308982 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 329742 0
Condition category
Condition code
Neurological 326640 326640 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an exploratory pilot open label trial that will assess the safety and feasibility of active transcranial Direct Current Stimulation (tDCS) in the home setting under caregiver and remote investigator supervision, activation and monitoring. Sessions will be supervised by a paediatric neurologist with a minimum of 10 years' experience,

tDCS stimulates the brain by using low levels of electricity to affect the activity and connections between brain cells. The electricity is applied using sponges placed at specific locations on the scalp. Participation will occur over five days for one hour each day. Active stimulation sessions will be 20 minutes in duration, at a current intensity of 1.5 mA. Individual participant tolerance will be assessed prior to stimulation sessions, and current intensity adjusted as necessary. The tDCS device used in the study is the Soterix Medical 1x1 Transcranial Direct Current Stimulator Mini - Clinical Trials (CT), model 1601. Accessories used will include head straps with disposable sponge pads; measuring tape, alcohol swabs, skin pencils and a Box and Blocks Test kit.

Caregiver training will be provided in the first intervention session by the supervising remote investigator. Caregivers will be shown two instructional videos, one to perform head measurements to select the correct sized headgear, and another to demonstrate tDCS device set up. The caregiver will then be stepped through both processes in real time by the supervising remote investigator. This process is estimated to take approximately 30 minutes. The caregiver will be asked to take a photograph of the device set up using their phone and upload this to REDCap for review by the study team. The intervention session will not progress until the set up has been reviewed by the study team and deemed to be correct.
At the beginning of every stimulation session thereafter, the caregiver will be stepped through the process of device set up in real time, and correct set up will again be reviewed by the study team following the process above. This process is estimated to take approximately 10 minutes. This process will always occur before proceeding with the stimulation. Adherence to the trial protocol will be monitored during the real-time set up process and via device analytics.
Intervention code [1] 325902 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334510 0
Safety of remotely-delivered tDCS, assessed via frequency and nature of adverse events reported pre-, during and post-stimulation. Adverse events include, but are not limited to, redness, tingling and itching at the electrode site. All adverse events are measured on a 4-point likert scale.
Timepoint [1] 334510 0
Stimulation sessions, days 1 - 5
Secondary outcome [1] 420955 0
Ease of tDCS device set up via pre-stimulation set up survey. This survey steps caregivers through each stage of the set up process and asks them to rate the difficulty of each step using a Likert scale. This survey has been adapted from Christopher et al (2023) Safety, tolerability and feasibility of remotely-instructed home-based transcranial direct current stimulation in children with cerebral palsy. Brain Stimulation, 16:1325-1327.
Timepoint [1] 420955 0
Stimulation sessions, days 1 - 5
Secondary outcome [2] 426638 0
Quality of device set up via electrode contact quality, recorded using feedback from the tDCS device throughout the session. The tDCS device has a coloured light that should remain green throughout the session, indicating good electrode contact quality. The number of times the coloured light is orange or red, indicating poor contact quality, will be recorded by the research team, along with the duration of time this occurs over the 20 minute stimulation period.
Timepoint [2] 426638 0
Stimulation sessions, days 2 - 5
Secondary outcome [3] 426639 0
Speed of tDCS device set up, measured using a REDCap timer at the beginning of the 'Pre-stimulation set up survey'. The survey steps caregivers through each stage of the set up process and asks them to rate the difficulty of each step. The timer is stopped at the end of the survey.
Timepoint [3] 426639 0
Stimulation sessions, days 1 - 5
Secondary outcome [4] 426640 0
Post-stimulation comfort and set up survey, measured via a series of questions assessing post-stimulation device positioning, participant comfort, and caregiver and participant feedback. This survey has been adapted from Christopher et al (2023) Safety, tolerability and feasibility of remotely-instructed home-based transcranial direct current stimulation in children with cerebral palsy. Brain Stimulation, 16:1325-1327.
Timepoint [4] 426640 0
Stimulation sessions, days 1 - 5

Eligibility
Key inclusion criteria
1. Aged between 8 years 0 days and 17 years 364 days
2. Children with a confirmed diagnosis of CP and a history of perinatal stroke or PVL
3. Receptive language function to follow two-step commands
4. Ability to report pain or discomfort through expressive language function or other
5. No or mild intellectual disability
6. Greater than or equal to 10 degrees of active motion at the metacarpophalangeal joint
7. Children who have had surgeries which may influence motor function (e.g., tendon transfer) will be included, and surgical history documented and included in any publication within a participant characteristics table.
8. Home set-up: Internet access and a working computer/laptop device, table suitable to perform Box and Blocks Test
9. Informed consent obtained by parent, and child/adolescent where appropriate. Assent sought from child/adolescent where consent cannot be obtained
Minimum age
8 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inaccessibility to internet or unreliable internet coverage
2. Conductive Implants
3. Abnormal cell growth (e.g., neoplasm)
4. Metabolic Disorders
5. Seizure within two years preceding the study
6. Acquired Traumatic Brain Injury
7. Known current pregnancy
8. Indwelling metal or incompatible medical devices
9. Evidence of skin disease or skin abnormalities on the scalp
10. Disorder of Cellular Migration and Proliferation
11. Concomitant participation in another neuromodulation study
12. Centrally-acting agent or other agent that may lower seizure threshold or affect cortical plasticity
13. Limited ability to communicate insight into a preferred future (needs, wants, desires) in spoken English or through augmentative/alternative communication

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The sample size of 10 is based on a similar but separate study running concurrently at the Pediatric Neuromodulation Laboratory (Waisman Center, University of Wisconsin-Madison, USA) with 10 participants. This study is open label, thus all participants will receive active tDCS stimulation. All participants will be included in the analysis for primary and secondary endpoints.

Primary endpoint: We will report the frequency of adverse events for each participant. This will be compared to the Pediatric Neuromodulation Laboratory's previous studies in this population, using chi-squared analyses to test for differences in frequency counts.

Secondary endpoints: We will determine changes in stimulation quality and speed over the three active sessions using a Friedman test (non-parametric test for repeated measures). Tests with a p-value of <0.05 will be considered significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2023
Actual
18/06/2024
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
10
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314301 0
Charities/Societies/Foundations
Name [1] 314301 0
Cerebral Palsy Alliance Research Foundation
Country [1] 314301 0
Australia
Funding source category [2] 314648 0
Charities/Societies/Foundations
Name [2] 314648 0
Brain Australia
Country [2] 314648 0
Australia
Funding source category [3] 314649 0
Charities/Societies/Foundations
Name [3] 314649 0
Thrasher Research Fund
Country [3] 314649 0
United States of America
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd, Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 316249 0
None
Name [1] 316249 0
Address [1] 316249 0
Country [1] 316249 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312428 0
Monash Health HREC A
Ethics committee address [1] 312428 0
Ethics committee country [1] 312428 0
Australia
Date submitted for ethics approval [1] 312428 0
17/05/2023
Approval date [1] 312428 0
07/06/2023
Ethics approval number [1] 312428 0
HREC/88381/MonH-2023-355157(v1)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124630 0
Prof Michael Fahey
Address 124630 0
School of Clinical Sciences, Monash Health246 Clayton RdClayton VIC 3168
Country 124630 0
Australia
Phone 124630 0
+61 3 8572 3757
Fax 124630 0
Email 124630 0
[email protected]
Contact person for public queries
Name 124631 0
Alex Griffin
Address 124631 0
Cerebral Palsy Alliance Research Institute Brain and Mind Centre, The University of SydneyLevel 4, 88 Mallet StCamperdown NSW 2050
Country 124631 0
Australia
Phone 124631 0
+61 2 8052 2071
Fax 124631 0
Email 124631 0
[email protected]
Contact person for scientific queries
Name 124632 0
Alex Griffin
Address 124632 0
Cerebral Palsy Alliance Research Institute The University of SydneyLevel 4, 88 Mallet StCamperdown NSW 2050
Country 124632 0
Australia
Phone 124632 0
+61 2 8052 2071
Fax 124632 0
Email 124632 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.