Clinical trial NCT04317950: Cortical Activity During Vojta Stimulation in Healthy Adults
Official title: Cortical Activity During Sensorial Tactile Stimulation in Healthy Adults. The Innate Patron Activation With Vojta Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain
Keywords: Electroencephalography
Electromyography
Tactile stimulation
Vojta therapy
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
Collaborators: name: Universidad Europea de Madrid
First posted: 2020-03-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The present study is focused on the importance of sensory stimuli at the tactile and proprioceptive level that occur during the activation of the pectoral area, following the treatment protocol of Vojta Therapy (VT), and which are the areas that are activated in the central nervous system (CNS) during stimulation, as well as muscle activity. For the activation record it will be used electroencephalography and electromyography electrods.

Detailed description: The relationship between intrinsic and extrinsic factors condition the development of the human being. The sensory organs are the main recipients of the information, thanks to them we are able to interact with the environment and register the influence of the stimuli inside the organism. The brain receives information from the environment through its senses.

At the tactile level the brain receives afferent information thanks to the activation of mechanoreceptors of the skin during interaction with the environment. The receivers encode the stimulus information and send it to the specific CNS structures. In these structures, the sensations received are combined and the stimulus is transformed into a perfectly elaborated response, both in a conscious and innate way.

Dr. Vojta showed in 1974 the locomotion reflects the result of the study of motor ontogenesis. This discovery was the demonstration of the existence of innate and preprogrammed motor patterns in Humans.

Most of the studies related to VT have showed the improvements obtained by the patients, validating it as a method of treatment and evidencing objective changes after its application. This research aim to go further and verify that cortical areas are activated during the application of an external and proprioceptive stimuli that are performed during the first phase of VT turning and which areas are responsible for producing and organizing the efferent response.

Eligibility criteria: Inclusion Criteria:

* Healthy adult population with no history of neurological disease or others that may affect the test.
* Age between 18 and 50 years.
* Not having addiction to alcohol or drugs at the time of the study.
* Not knowing the basics of Vojta Therapy, or knowing the responses of stimuli when applying therapy.
* Not having the pharmacological treatment that affects the functioning of the Central Nervous System and may interfere with the test results.

Exclusion Criteria:

* Those who do not meet the inclusion criteria
* Not having suffered ms-skeletal alterations in the last 6 months.
* Known sensory abnormalities.
* Diagnosis of some neurological pathology or condition that could alter the study such as pain, radiculopathy.
* Refuse to sign the informed consent.
* Claustrophobia.
* Those that can spoil the magnetic resonance image.

  * Be a carrier of some metallic material.
  * Pregnancy or nursing mother.
* The contraindications of Vojta Therapy.

  * Acute diseases that present with fever and / or inflammation.
  * Vaccination with live germs, according to medical criteria (usually 10 days after vaccination).
  * In case of crystal bone disease, uncontrolled heart disease.

Primary outcomes:
measure: Electroencephalography (EEG)
timeFrame: 10 minutes per patient
measure: Electromyography (EMG)
timeFrame: 10 minutes per patient
Secondary outcomes:
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Roberto Cano de la Cuerda
state: Madrid
Study officials:
affiliation: UEM
name: Ismael Sanz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sanz-Esteban I, Cano-de-la-Cuerda R, San-Martin-Gomez A, Jimenez-Antona C, Monge-Pereira E, Estrada-Barranco C, Serrano JI. Cortical activity during sensorial tactile stimulation in healthy adults through Vojta therapy. A randomized pilot controlled trial. J Neuroeng Rehabil. 2021 Jan 21;18(1):13. doi: 10.1186/s12984-021-00824-4.