HEMI-STIM. tDCS and Intensive Therapies

Infantile Hemiplegia Clinical Trial

Official title:

Transcranial Direct Current Combined With Intensive Therapies in Infantile Hemiplegia. Triple-blind Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05226910
• Other study ID #: Rpalomo01
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: January 2023
• Source: University of Castilla-La Mancha
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 1, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Hemiplegia
• Infantile Hemiplegia

Intervention

Device:
• tDCS and intensive therapies
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 therapies
This intervention will consist in the combination of sham tDCS with CIMT (30 hours) and then with BIT (3 hours and 45 minutes)

Locations

Country	Name	City	State
Spain	University of Castilla-La Mancha	Toledo

Sponsors (1)

Lead Sponsor	Collaborator
University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View Citation

Gordon 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. — View Citation

Hoare 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. — View Citation

Page 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, post-treatment (at 13 days), and follow-up at 12 weeks
Secondary	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.	Baseline, post-treatment (at 13 days), and follow-up at 12 weeks
Secondary	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.	Baseline, post-treatment (at 13 days), and follow-up at 12 weeks