Infantile HemiplegiaNCT05226910
HEMI-STIM. tDCS and Intensive Therapies
A study testing tDCS and intensive therapies in people with Infantile Hemiplegia, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
Application of Transcranial Direct Current or placebo combined with Constraint Induced Movement Therapy (CIMT) and bimanual intensive therapy (BIT) in infantile hemiplegia (4-8 years). Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Infantile Hemiplegia
- What is being tested?
- tDCS and intensive therapies
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2021to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between 4 and 8 years old, with a diagnosis of congenital infantile hemiplegia, with a score between levels I and III of the manual ability classification system (MACS) and a level I-III of the gross motor function classification system will be included (GMFCS). In addition, children must have a preserved cognitive ability to understand the execution of structured activities
Who cannot join
- Having previously been treated with tDCS; Having been infiltrated with botulinum toxin 2 months prior to the intervention; Surgery of the upper limb the 6 months prior to the intervention; Pharmacologically uncontrolled epilepsy or having suffered epileptic seizures in the two years prior to the study (according to international recommendations for tDCS in children, Gillick et al., 2018); Contraindications of tDCS according to international recommendations. In addition, a withdrawal criterion will be non-attendance for more than 20% of the hours of the program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Direct Current Combined With Intensive Therapies in Infantile Hemiplegia. Triple-blind Randomized Clinical Trial
Application of Transcranial Direct Current or placebo combined with Constraint Induced Movement Therapy (CIMT) and bimanual intensive therapy (BIT) in infantile hemiplegia (4-8 years). Before, after the treatment and 3 months after the treatment, the functionality of the affected upper limb will be assessed: Spontaneous use, alignment of the affected segment in movement, action of grasping and releasing an object with the wrist in a neutral position, extension and flexion and quality of life. CIMT will last 3 hours per day in a period of two weeks (10 days from M-F), and the transcranial direct current or placebo will be combined during the first 20 minutes of it. In addition, 45 minutes of BIT will be performed during the third week (3 days). The total time of the therapy will be 33 hours and 45 minutes. CIMT and BIT will have a playful and group performance model.
Read the detailed description
Objectives: To determine the efficacy of the combined application of transcranial direct current (tDCS) with a restraint-induced movement therapy program and bimanual therapy on quality of life, quality of movement and spontaneous use of the affected upper limb in children. with infantile hemiparesis.
Design: Randomized clinical trial with triple blind placebo control. Participants: 30 children between 4 and 8 years old diagnosed with infantile hemiparesis randomized into two groups.
Intervention: Program of 15 sessions (3 weeks) in which 20 minutes of cathodic tDCS (active or placebo) will be applied during the performance of 3 hours of restriction-induced movement therapy (CIMT) in the first two weeks and with 45 minutes of bimanual intensive therapy (TIB) in the third week. The effective duration of the intervention will be 33 hours and 45 minutes.
Variables: The outcome variables will be recorded before the intervention program, just after and three months after its completion.
Analysis: An intention-to-treat analysis will be performed. For the main result variables, a two-factor ANOVA (intervention-time) will be performed with a post-hoc analysis with Bonferroni correction.
- Conditions
- Infantile Hemiplegia
- Being tested
- tDCS and intensive therapies, Sham and intensive therapies
- Keywords
- infantile hemiplegia, upper extremity, transcranial direct current, children
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS and intensive therapiesDevice
This intervention will consist in the combination of tDCS with CIMT (30 hours) and then with BIT (3 hours and 45 minutes)
Sham and intensive therapiesDevice
This intervention will consist in the combination of sham tDCS with CIMT (30 hours) and then with BIT (3 hours and 45 minutes)
| Study group | Role | What they receive |
|---|---|---|
| tDCS and intensive therapies | Experimental | Cathodal tDCS and constraint induce movement therapy Receives: Device: tDCS and intensive therapies |
| Sham and intensive therapies | Sham comparator | Sham tDCS and constraint induce movement therapy Receives: Device: Sham and intensive therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the spontaneous use of affected upper limb
This outcome will be assessed with Shuee evaluation. This evaluation uses the modified House scale which a maximum of 45 points can be obtained for the spontaneous use, and the values obtained can be converted into percentages. In addition, the dynamic positioning of the affected upper extremity is assessed through 16 structured activities in the Shuee evaluation (Positioning of the thumb, fingers, wrist, elbow, and forearm).
TAcquiring a maximum score of 72 and their values can be considered in percentages. Another of the measured variables into the Shuee evaluation is the action of grasping and releasing an object with the wrist joint in different positions (results provided in percentages). This evaluation is validated for children with hemiplegia from 3 to 18 years old.
Measured: Baseline, post-treatment (at 13 days), and follow-up at 12 weeks
Secondary outcomes (2)
Change in the experience of use of the affected upper limb
This outcome will be assessed with CHEQ questionnaire. It is validated for children with have reduction in the upper limb from 8 to 18 years old. It is a questionnaire composed of 27 questions about the activities of daily life and the execution of the task. Whether it is done with one hand, with both hands or with help and how effective is the use of the affected hand on a scale of 1-4, the time of execution of the task on a scale of 1-4 and the discomfort of execution of it on a scale of 1-4. It can be answered by the family, the therapist or the child himself from the age of 13.
Measured: Baseline, post-treatment (at 13 days), and follow-up at 12 weeks
Change in the Quality of life in cerebral palsy
Use the PedsQL questionnaire to measure the quality of life. It is a questionnaire answered by the parents with children with cerebral palsy from 2-18 years old. It is made up of 35 items that describe different situations in the child's life. The questionnaire has different domains related to the physical activities, school activities, emotional activities, hygiene. The maximum score obtained can be 100 (0-100), which indicates that the higher the score, the better the quality of life.
Measured: Baseline, post-treatment (at 13 days), and follow-up at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start1 Oct 2021
- Primary completion30 Jul 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Infantile HemiplegiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups: tDCS and Intensive therapies (experimental group), placebo and intensive therapies (control group)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julio Gómez-Soriano, PhD, Principal investigator, Castilla-La Mancha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226910
- Sponsor's protocol ID
- Rpalomo01
- Status last verified
- Jan 2023
- First submitted
- 14 Jan 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share all data researchers need
Publications
Alisar DC, Ozen S, Sozay S. Effects of Bihemispheric Transcranial Direct Current Stimulation on Upper Extremity Function in Stroke Patients: A randomized Double-Blind Sham-Controlled Study. J Stroke Cerebrovasc Dis. 2020 Jan;29(1):104454. doi: 10.1016/j.jstrokecerebrovasdis.2019.104454. Epub 2019 Nov 4.
PubMed 31699572Page SJ, Cunningham DA, Plow E, Blazak B. It takes two: noninvasive brain stimulation combined with neurorehabilitation. Arch Phys Med Rehabil. 2015 Apr;96(4 Suppl):S89-93. doi: 10.1016/j.apmr.2014.09.019.
PubMed 25813373Hoare BJ, Wallen MA, Thorley MN, Jackman ML, Carey LM, Imms C. Constraint-induced movement therapy in children with unilateral cerebral palsy. Cochrane Database Syst Rev. 2019 Apr 1;4(4):CD004149. doi: 10.1002/14651858.CD004149.pub3.
PubMed 30932166Gordon AM, Hung YC, Brandao M, Ferre CL, Kuo HC, Friel K, Petra E, Chinnan A, Charles JR. Bimanual training and constraint-induced movement therapy in children with hemiplegic cerebral palsy: a randomized trial. Neurorehabil Neural Repair. 2011 Oct;25(8):692-702. doi: 10.1177/1545968311402508. Epub 2011 Jun 23.
PubMed 21700924
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Combined With Intensive Therapies in Infantile Hemiplegia. Triple-blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05226910
- Acronym / sponsor ID
- Rpalomo01
- Conditions
- Infantile Hemiplegia
- Keywords
- infantile hemiplegia, upper extremity, transcranial direct current, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Application of Transcranial Direct Current or placebo combined with Constraint Induced Movement Therapy (CIMT) and bimanual intensive therapy (BIT) in infantile hemiplegia (4-8 years). Before, after the treatment and 3 months after the treatment, the functionality of the affected upper limb will be assessed: Spontaneous use, alignment of the affected segment in movement, action of grasping and releasing an object with the wrist in a neutral position, extension and flexion and quality of life. CIMT will last 3 hours per day in a period of two weeks (10 days from M-F), and the transcranial direct current or placebo will be combined during the first 20 minutes of it. In addition, 45 minutes of BIT will be performed during the third week (3 days). The total time of the therapy will be 33 hours and 45 minutes. CIMT and BIT will have a playful and group performance model.
Detailed description
Objectives: To determine the efficacy of the combined application of transcranial direct current (tDCS) with a restraint-induced movement therapy program and bimanual therapy on quality of life, quality of movement and spontaneous use of the affected upper limb in children. with infantile hemiparesis.
Design: Randomized clinical trial with triple blind placebo control. Participants: 30 children between 4 and 8 years old diagnosed with infantile hemiparesis randomized into two groups.
Intervention: Program of 15 sessions (3 weeks) in which 20 minutes of cathodic tDCS (active or placebo) will be applied during the performance of 3 hours of restriction-induced movement therapy (CIMT) in the first two weeks and with 45 minutes of bimanual intensive therapy (TIB) in the third week. The effective duration of the intervention will be 33 hours and 45 minutes.
Variables: The outcome variables will be recorded before the intervention program, just after and three months after its completion.
Analysis: An intention-to-treat analysis will be performed. For the main result variables, a two-factor ANOVA (intervention-time) will be performed with a post-hoc analysis with Bonferroni correction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups: tDCS and Intensive therapies (experimental group), placebo and intensive therapies (control group)
| Arm | Type | Receives |
|---|---|---|
| tDCS and intensive therapies | Experimental | Device: tDCS and intensive therapiesCathodal tDCS and constraint induce movement therapy |
| Sham and intensive therapies | Sham comparator | Device: Sham and intensive therapiesSham tDCS and constraint induce movement therapy |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between 4 and 8 years old, with a diagnosis of congenital infantile hemiplegia, with a score between levels I and III of the manual ability classification system (MACS) and a level I-III of the gross motor function classification system will be included (GMFCS). In addition, children must have a preserved cognitive ability to understand the execution of structured activities
Key exclusion criteria (1 listed)
- Having previously been treated with tDCS; Having been infiltrated with botulinum toxin 2 months prior to the intervention; Surgery of the upper limb the 6 months prior to the intervention; Pharmacologically uncontrolled epilepsy or having suffered epileptic seizures in the two years prior to the study (according to international recommendations for tDCS in children, Gillick et al., 2018); Contraindications of tDCS according to international recommendations. In addition, a withdrawal criterion will be non-attendance for more than 20% of the hours of the program.
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 |
|---|---|---|
| tDCS and intensive therapiesThis intervention will consist in the combination of tDCS with CIMT (30 hours) and then with BIT (3 hours and 45 minutes) | Device | tDCS and intensive therapies |
| Sham and intensive therapiesThis intervention will consist in the combination of sham tDCS with CIMT (30 hours) and then with BIT (3 hours and 45 minutes) | Device | Sham and intensive therapies |
Primary outcome
Change of the spontaneous use of affected upper limb
Time frame: Baseline, post-treatment (at 13 days), and follow-up at 12 weeks
This outcome will be assessed with Shuee evaluation. This evaluation uses the modified House scale which a maximum of 45 points can be obtained for the spontaneous use, and the values obtained can be converted into percentages. In addition, the dynamic positioning of the affected upper extremity is assessed through 16 structured activities in the Shuee evaluation (Positioning of the thumb, fingers, wrist, elbow, and forearm). TAcquiring a maximum score of 72 and their values can be considered in percentages. Another of the measured variables into the Shuee evaluation is the action of grasping and releasing an object with the wrist joint in different positions (results provided in percentages). This evaluation is validated for children with hemiplegia from 3 to 18 years old.
2 secondary outcomes
Change in the experience of use of the affected upper limb
Time frame: Baseline, post-treatment (at 13 days), and follow-up at 12 weeks
Change in the Quality of life in cerebral palsy
Time frame: Baseline, post-treatment (at 13 days), and follow-up at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Background: PubMed 31699572Alisar DC, Ozen S, Sozay S. Effects of Bihemispheric Transcranial Direct Current Stimulation on Upper Extremity Function in Stroke Patients: A randomized Double-Blind Sham-Controlled Study. J Stroke Cerebrovasc Dis. 2020 Jan;29(1):104454. doi: 10.1016/j.jstrokecerebrovasdis.2019.104454. Epub 2019 Nov 4.
- Background: PubMed 25813373Page SJ, Cunningham DA, Plow E, Blazak B. It takes two: noninvasive brain stimulation combined with neurorehabilitation. Arch Phys Med Rehabil. 2015 Apr;96(4 Suppl):S89-93. doi: 10.1016/j.apmr.2014.09.019.
- Background: PubMed 30932166Hoare BJ, Wallen MA, Thorley MN, Jackman ML, Carey LM, Imms C. Constraint-induced movement therapy in children with unilateral cerebral palsy. Cochrane Database Syst Rev. 2019 Apr 1;4(4):CD004149. doi: 10.1002/14651858.CD004149.pub3.
- Background: PubMed 21700924Gordon AM, Hung YC, Brandao M, Ferre CL, Kuo HC, Friel K, Petra E, Chinnan A, Charles JR. Bimanual training and constraint-induced movement therapy in children with hemiplegic cerebral palsy: a randomized trial. Neurorehabil Neural Repair. 2011 Oct;25(8):692-702. doi: 10.1177/1545968311402508. Epub 2011 Jun 23.
- Individual participant dataSharing planned: Yes. We will share all data researchers need
Related trials for Infantile Hemiplegia
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Using Power Mobility Training to Promote Arm & Hand Function in Children With Cerebral Palsy
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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.
Julio Gómez-Soriano, PhD principal investigator
Castilla-La Mancha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS and intensive therapies in people with Infantile Hemiplegia, run by University of Castilla-La Mancha at 1 site in Spain.
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 1 inclusion and 1 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 18 Jan 2023. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of the spontaneous use of affected upper limb (time frame: Baseline, post-treatment (at 13 days), and follow-up at 12 weeks). 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 NCT05226910, 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 18 Jan 2023.