Heart Rate VariabilityTMSXHRVNCT03739489
Effects of Repetitive Transcranial Magnetic Stimulation on Heart Rate Variability
A study testing Repetitive transcranial magnetic stimulation in people with Heart Rate Variability, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Repetitive transcranial magnetic stimulation is a non-invasive neuromodulation technique used to treat different neuropsychiatric disorders, such as, depression, neuropathic pain, fibromyalgia and obsessive-compulsive disorder. It is known that the heart rate variability is altered in these conditions. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Rate Variability
- What is being tested?
- Repetitive transcranial magnetic stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2018to Dec 2018
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Agreed participate the protocol
- Signing the consent form
- Do not present any cardiac problems or disease
Who cannot join
- Trauma of Skull, epilepsy don't treated,
- Use of medications decrease the seizure threshold
- Patients in use of drugs, how cocaine and alcohol
- Neurosurgical clips, pacemakers, increased intracranial pressure (risk of sequelae after seizure)
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP)
São Paulo, São Paulo, 05403900
About this study
Repetitive transcranial magnetic stimulation is a non-invasive neuromodulation technique used to treat different neuropsychiatric disorders, such as, depression, neuropathic pain, fibromyalgia and obsessive-compulsive disorder. It is known that the heart rate variability is altered in these conditions. Therefore the focus of this research is to show the influence of rTMS on the Heart Rate Variability.
- Conditions
- Heart Rate Variability
- Being tested
- Repetitive transcranial magnetic stimulation
- Keywords
- healthy subjects, repetitive transcranial magnetic stimulation, heart rate variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulationProcedure or surgery
Repetitive transcranial magnetic stimulation was a technique able to modulate the brain circuit restoring the function.
| Study group | Role | What they receive |
|---|---|---|
| rTMS-PSI | Active comparator | Participants allocated in this arm will receive active repetitive transcranial magnetic stimulation over the posterior superior insula right. Receives: Procedure: Repetitive transcranial magnetic stimulation |
| rTMS-M1 | Active comparator | Participants allocated in this arm will receive active repetitive transcranial magnetic stimulation over the right primary motor cortex. Receives: Procedure: Repetitive transcranial magnetic stimulation |
| rTMS-F3 | Active comparator | Participants allocated in this arm will receive active repetitive transcranial magnetic stimulation over the left pre frontal dorsolateral cortex. Receives: Procedure: Repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability changes
Changes in heart rate variability measured by Polar V800
Measured: Three times during the entire study. Following the scheme, Until 1 hour before each session, 15 minutes along the each session and until 1 hour after the end of session
Secondary outcomes (2)
Conditioned Pain Modulation
change in pain units on a scale of 0-100. 0 no pain. 100 = the maximum pain
Measured: 48 hours before the first session of stimulation
Volume in
Determine if volume cortical regions can serve as biomarkers to predict rTMS treatment response in Healthy volunteers
Measured: 1 week before the first session of stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start1 Apr 2018
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rate VariabilityStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The participant will be received three different sessions of rtms, with wash out 30 days between sessions.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Galhardoni, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739489
- Sponsor's protocol ID
- RG-02
- Acronym
- TMSXHRV
- Status last verified
- Nov 2018
- First submitted
- 28 Mar 2018
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Repetitive Transcranial Magnetic Stimulation on Heart Rate Variability
- ClinicalTrials.gov ID
- NCT03739489
- Acronym / sponsor ID
- TMSXHRV / RG-02
- Conditions
- Heart Rate Variability
- Keywords
- healthy subjects, repetitive transcranial magnetic stimulation, heart rate variability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 13 Nov 2018 (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.
Repetitive transcranial magnetic stimulation is a non-invasive neuromodulation technique used to treat different neuropsychiatric disorders, such as, depression, neuropathic pain, fibromyalgia and obsessive-compulsive disorder. It is known that the heart rate variability is altered in these conditions. Therefore the focus of this research is to show the influence of rTMS on the Heart Rate Variability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The participant will be received three different sessions of rtms, with wash out 30 days between sessions.
| Arm | Type | Receives |
|---|---|---|
| rTMS-PSI | Active comparator | Procedure: Repetitive transcranial magnetic stimulationParticipants allocated in this arm will receive active repetitive transcranial magnetic stimulation over the posterior superior insula right. |
| rTMS-M1 | Active comparator | Procedure: Repetitive transcranial magnetic stimulationParticipants allocated in this arm will receive active repetitive transcranial magnetic stimulation over the right primary motor cortex. |
| rTMS-F3 | Active comparator | Procedure: Repetitive transcranial magnetic stimulationParticipants allocated in this arm will receive active repetitive transcranial magnetic stimulation over the left pre frontal dorsolateral cortex. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Agreed participate the protocol
- Signing the consent form
- Do not present any cardiac problems or disease
Key exclusion criteria (5 listed)
- Trauma of Skull, epilepsy don't treated,
- Use of medications decrease the seizure threshold
- Patients in use of drugs, how cocaine and alcohol
- Neurosurgical clips, pacemakers, increased intracranial pressure (risk of sequelae after seizure)
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Repetitive transcranial magnetic stimulationRepetitive transcranial magnetic stimulation was a technique able to modulate the brain circuit restoring the function. | Procedure or surgery | rTMS-F3, rTMS-M1, rTMS-PSI |
Primary outcome
Heart rate variability changes
Time frame: Three times during the entire study. Following the scheme, Until 1 hour before each session, 15 minutes along the each session and until 1 hour after the end of session
Changes in heart rate variability measured by Polar V800
2 secondary outcomes
Conditioned Pain Modulation
Time frame: 48 hours before the first session of stimulation
Volume in
Time frame: 1 week before the first session of stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation in people with Heart Rate Variability, run by University of Sao Paulo at 1 site in Brazil.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Nov 2018. 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 Brazil. 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. 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?
Results are not available in the source record.
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?
Heart rate variability changes (time frame: Three times during the entire study. Following the scheme, Until 1 hour before each session, 15 minutes along the each session and until 1 hour after the end of session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2018.