HEMI-STIM. tDCS and Intensive Therapies

NCT ID: NCT05226910

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-10-01

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

tDCS and intensive therapies

Cathodal tDCS and constraint induce movement therapy

Group Type: EXPERIMENTAL

tDCS and intensive therapies

Intervention Type: DEVICE

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

Sham tDCS and constraint induce movement therapy

Group Type: SHAM_COMPARATOR

Sham and intensive therapies

Intervention Type: DEVICE

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

Interventions

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)

Intervention Type: DEVICE

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)

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Castilla-La Mancha

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julio Gómez-Soriano, PhD

Role: PRINCIPAL_INVESTIGATOR

Castilla-La Mancha University

Locations

University of Castilla-La Mancha

Toledo, , Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 31699572 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25813373 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30932166 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21700924 (View on PubMed)

Other Identifiers

Rpalomo01

Identifier Type: -

Identifier Source: org_study_id