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Effects of Photobiomodulation on Superficial Sensitivity and Muscle Activity of Individuals With Myelomeningocele

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04035863
Recruitment Status : Not yet recruiting
First Posted : July 29, 2019
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Sandra Kalil Bussadori, University of Nove de Julho

Brief Summary:
Myelomeningocele is a neural tube defect that occurs between the third and fourth week of gestation. Functional impairment occurs due to dysplasia of the nerve roots, which can lead to flaccid paralysis and sensory-motor dysfunction below the level of the lesion. Although advances in the multidisciplinary treatment of myelomeningocele have led to functional improvements in affected children, novel therapeutic modalities, such as photobiomodulation (PBM), could be a promising complement to treatment. Objective: Evaluate the effectiveness of PBM combined with physiotherapeutic exercises on the sensory-motor response in individuals with myelomeningocele at the lower lumbar and sacral level. Participants will be recruited from the Integrated Health Clinic of University Nove de Julho and randomized into two groups: Grupo 1 - treatment with PBM at a wavelength of 808 nm + physical therapy; Grupo 2 - sham PBM + physical therapy. Evaluations will involve electromyography of the gastrocnemius, tibialis anterior and rectus femoris muscles of both lower limbs. Balance will be evaluated using the Pediatric Balance Scale. The sensory evaluation will be performed using the Semmes-Weinstein monofilament kit (Smiles®). BDNF levels will be determined using ELISA. The data will be analyzed with the aid of GraphPad PRISM version 7.0. The Kolmogorov-Smirnov test will be used to determine the normality of the data. Variables that fit the Gaussian curve will be expressed as mean and standard deviation values. The t-test will be used for the comparisons between groups, with the level of significance set to 95% (p < 0.05).

Condition or disease Intervention/treatment Phase
Myelomeningocele Without Hydrocephalus Sensory Defect Motor Activity Device: Low level laser therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: EVALUATION OF THE SENSORY-MOTOR RESPONSE IN PATIENTS WITH MYELOMENINGOCELE FOLLOWING TREATMENT WITH PHOTOBIOMODULATION
Estimated Study Start Date : September 2, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : May 3, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PBM + physiotherapy exercises

will be submitted to active PBM and physiotherapeutic exercises.

For irradiation, the individuals will be positioned comfortably in lateral decubitus on the examining table. Three points will be irradiated at the lesion level with a wavelength of 808 nm, 25 J per point for 12 sessions. The same laser device (Laser DMC Therapy EC).

Physical therapy will occur twice per week after PBM for six weeks. Static balance exercises will be performed with the feet together and tandem on a variety of different surfaces (hard surface, foam rubber and carpets with different textures) and sensory inputs (eyes open and closed). Dynamic balance exercises will involve walking forward and backward on firm and foam surfaces and circumventing obstacles. Muscle strengthening exercises, squatting and changing postural positions will also be performed. All activities will be in the form of play to maintain the children's interest

Device: Low level laser therapy

For the PBM protocol, articles of interest were identified through analyses of titles and abstracts. Articles addressing PBM in experimental models or clinical trials of spinal cord injuries were included and articles not pertinent to the proposed study were excluded. Next, the selected articles were analyzed and used for the creation of an initial protocol (Table 1).

For irradiation, the individuals will be positioned comfortably in lateral decubitus on the examining table. Three points will be irradiated above the lesion level, which will be located using an imaging exam brought by the guardian on the day of the evaluation. After determining the lesion level, palpation of the transverse processes of the vertebrae will be performed. The same laser device (Laser DMC Therapy EC) will be used for both groups. For the placebo group, the device will emit sound but not light.


Sham Comparator: SHAM PBM + physiotherapy exercises

will be submitted to sham PBM and physiotherapeutic exercises.

For irradiation sham, the individuals will be positioned comfortably in lateral decubitus on the examining table. The same laser device (Laser DMC Therapy EC) will be used but the device will emit sound but not light.

Physical therapy will occur twice per week after PBM for six weeks. Static balance exercises will be performed with the feet together and tandem on a variety of different surfaces (hard surface, foam rubber and carpets with different textures) and sensory inputs (eyes open and closed). Dynamic balance exercises will involve walking forward and backward on firm and foam surfaces and circumventing obstacles. Muscle strengthening exercises, squatting and changing postural positions will also be performed. All activities will be in the form of play to maintain the children's interest

Device: Low level laser therapy

For the PBM protocol, articles of interest were identified through analyses of titles and abstracts. Articles addressing PBM in experimental models or clinical trials of spinal cord injuries were included and articles not pertinent to the proposed study were excluded. Next, the selected articles were analyzed and used for the creation of an initial protocol (Table 1).

For irradiation, the individuals will be positioned comfortably in lateral decubitus on the examining table. Three points will be irradiated above the lesion level, which will be located using an imaging exam brought by the guardian on the day of the evaluation. After determining the lesion level, palpation of the transverse processes of the vertebrae will be performed. The same laser device (Laser DMC Therapy EC) will be used for both groups. For the placebo group, the device will emit sound but not light.





Primary Outcome Measures :
  1. Assessment of muscle activity [ Time Frame: 10 minutes ]
    Electromyography (EMG) will be performed with the EMG System®. The participants will be placed on an examining table and the skin will be cleaned with tissues soaked in alcohol for the placement of the markers. Disposable self-adhesive Ag/AgCl surface electrodes (Noraxon) measuring 10 mm in diameter will be attached to the belly of the lateral gastrocnemius, tibialis anterior and rectus femoris muscles on both lower limbs to capture the EMG signals. A reference electrode will be placed on the left wrist of the volunteers to impede interference of external noise

  2. Sensory evaluation - monofilaments [ Time Frame: 10 minutes ]
    The sensory evaluation will be performed using the Semmes-Weinstein kit (Smiles®), which is a set of six nylon monofilaments of the same length that exert force on the specific area tested. Each monofilament has a different color and diameter: green (0.05 g), blue (0.2 g), violet (2 g), red (4 g), orang (10 g) and magenta (300 g). The score ranges from seven (green monofilament) to 1 (magenta monofilament). The test will be performed on the following dermatomes: L1, L2, L4, L5, S1, S2 and S3.


Secondary Outcome Measures :
  1. Evaluation of balance [ Time Frame: 10 minutos ]
    Balance will be evaluated using the Pediatric Balance Scale, which consists of 14 items scored from 0 to 4 points. The maximum score is 56, with higher scores denoting better balance.

  2. Analysis expression of brain-derived neurotrophic factor (BDNF) [ Time Frame: 10 minutes ]

    BDNF be quantified in saliva samples from the participants using ELISA MAX HUMAN kits (BioLegend), which contain capture and detection antibodies for the precise quantification of each cytokine. All kits will be used following the manufacturer's instructions. The optical density of the samples will be measured in a spectrophotometer at 450 nm.

    Collection of saliva


  3. Analysis expression Interleukin-10 (IL-10) [ Time Frame: 10 minutes ]
    IL-10 will be quantified in saliva samples from the participants using ELISA MAX HUMAN kits (BioLegend), which contain capture and detection antibodies for the precise quantification of each cytokine. All kits will be used following the manufacturer's instructions. The optical density of the samples will be measured in a spectrophotometer at 450 nm.



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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 5 to 16 years;
  • diagnosis of myelomeningocele on the lower lumbar and sacral level;
  • community ambulator;
  • score above the cutoff point for age on the Mini Mental State Examination.

Exclusion Criteria:

  • Cognitive impairment that compromises the ability to communicate and answer the questions that will be posed;
  • allergy to latex; - manifestations secondary to MMC, such as hydrocephalus;
  • congenital club foot; neuromuscular scoliosis;
  • subluxation or luxation of hip and knee;
  • other disease of the central nervous system, neoplasms, heart failure, renal, respiratory, hepatic.
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Responsible Party: Sandra Kalil Bussadori, Principal Investigator, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT04035863    
Other Study ID Numbers: MieloTamiris
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hydrocephalus
Meningomyelocele
Spina Bifida Cystica
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neural Tube Defects
Nervous System Malformations
Congenital Abnormalities
Spinal Dysraphism