HEMI-STIM. tDCS and Intensive Therapies

NCT05226910 | Completed

• 1 other identifier: Rpalomo01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Infantile Hemiplegia

Keywords

infantile hemiplegia; upper extremity; transcranial direct current; children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in the experience of use of the affected upper limb

  Baseline, post-treatment (at 13 days), and follow-up at 12 weeks

• Change in the Quality of life in cerebral palsy

  Baseline, post-treatment (at 13 days), and follow-up at 12 weeks

Study Arms (2)

tDCS and intensive therapies

EXPERIMENTAL

Cathodal tDCS and constraint induce movement therapy

Device: tDCS and intensive therapies

Sham and intensive therapies

SHAM COMPARATOR

Sham tDCS and constraint induce movement therapy

Device: Sham and intensive therapies

Interventions

tDCS and intensive therapies DEVICE

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

tDCS and intensive therapies

Sham and intensive therapies DEVICE

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

Sham and intensive therapies

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Castilla-La Mancha: lead

Study Sites (1)

University of Castilla-La Mancha

Toledo, 45071, Spain

Location

Related 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.

  PMID: 31699572 BACKGROUND

• 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.

  PMID: 25813373 BACKGROUND

• 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.

  PMID: 30932166 BACKGROUND

• 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.

  PMID: 21700924 BACKGROUND

MeSH Terms

Conditions

Hemiplegia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Julio Gómez-Soriano, PhD

  Castilla-La Mancha University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: It is a blind triple randomized clinical trial where patients, families and assessors are blinded and they do not know if the child is with placebo or current while is performing intensive therapies.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups: tDCS and Intensive therapies (experimental group), placebo and intensive therapies (control group)

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 7, 2022
• Study Start: October 1, 2021
• Primary Completion: July 30, 2022
• Study Completion: October 1, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Following article publication
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent ethical committee identified for this purpose. The proposal should be directed to principal investigator.

Locations

ES (1)