BrainNCT04317950
Cortical Activity During Vojta Stimulation in Healthy Adults
A study testing Vojta in people with Brain, run by Josue Fernandez Carnero at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain
- What is being tested?
- Vojta
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jan 2020to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cortical Activity During Sensorial Tactile Stimulation in Healthy Adults. The Innate Patron Activation With Vojta Therapy.
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.
Read the 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.
- Conditions
- Brain
- Being tested
- Vojta, Sham
- Keywords
- Electroencephalography, Electromyography, Tactile stimulation, Vojta therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VojtaOther
Reflex locomotion stimulus
ShamOther
sham stimulus
| Study group | Role | What they receive |
|---|---|---|
| Vojta group | Other | All participants were properly instructed and signed an informed consent previous to the interventions. They were comfortably laid down on their back with eyes open, wearing the EEG cap and electromyography electrodes during the intervention. They were asked to remain relaxed and still during the whole process. After a first minute of resting, the experimental group received a continuous reflex locomotion stimulus during the next 8 minutes. Receives: Other: Vojta |
| Control group | Sham comparator | On the contrary, the control group received a continuous sham stimulus during the next 8 minutes. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalography (EEG)
EEG power in alpha and beta bands
Measured: 10 minutes per patient
Electromyography (EMG)
EMG power in Rectus abdominis, wrist extensors and tibialis anterior
Measured: 10 minutes per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start8 Jan 2020
- Primary completion1 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Josue Fernandez Carnero
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Europea de Madrid
- Responsible party
- Sponsor-investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
- Investigators
- Ismael Sanz, PhD, Principal investigator, UEM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317950
- Sponsor's protocol ID
- UEMURJC
- Status last verified
- Feb 2021
- First submitted
- 28 Feb 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33478517
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Activity During Sensorial Tactile Stimulation in Healthy Adults. The Innate Patron Activation With Vojta Therapy.
- ClinicalTrials.gov ID
- NCT04317950
- Acronym / sponsor ID
- UEMURJC
- Conditions
- Brain
- Keywords
- Electroencephalography, Electromyography, Tactile stimulation, Vojta therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Josue Fernandez CarneroUniversity, hospital or other
- Collaborators
- Universidad Europea de Madrid
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 23 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vojta group | Other | Other: VojtaAll participants were properly instructed and signed an informed consent previous to the interventions. They were comfortably laid down on their back with eyes open, wearing the EEG cap and electromyography electrodes during the intervention. They were asked to remain relaxed and still during the whole process. After a first minute of resting, the experimental group received a continuous reflex locomotion stimulus during the next 8 minutes. |
| Control group | Sham comparator | Other: ShamOn the contrary, the control group received a continuous sham stimulus during the next 8 minutes. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VojtaReflex locomotion stimulus | Other | Vojta group |
| Shamsham stimulus | Other | Control group |
Primary outcome
Electroencephalography (EEG)
Time frame: 10 minutes per patient
EEG power in alpha and beta bands
Electromyography (EMG)
Time frame: 10 minutes per patient
EMG power in Rectus abdominis, wrist extensors and tibialis anterior
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Derived from this study: PubMed 33478517Sanz-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ismael Sanz, PhD principal investigator
UEM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vojta in people with Brain, run by Josue Fernandez Carnero at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalography (EEG) (time frame: 10 minutes per patient). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04317950, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.