StrokeNCT02956096
Evaluation of Autonomic Modulation in Stroke After Transcranial Direct Current Stimulation and Treadmill Training
A study testing Transcranial direct current stimulation (tDCS) and training on the running belt in people with Stroke, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Introduction: Patients post-stroke may have autonomic dysfunction, with increased blood pressure, heart rate (HR) and increased risk of sudden death. Studies have shown that transcranial direct-current stimulation (tDCS) can modulate the autonomic nervous system in healthy subjects, but little is known about these… Read more about this study
- Who is it for?
- Ages 21 to 74 years
- Conditions the study is for
- Stroke
- What is being tested?
- Transcranial direct current stimulation (tDCS) and training on the running belt
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2016to Nov 2017
- 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 21 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- present hemiparesis due to stroke for more than 6 months;
- Commitment mild or moderate motor in the lower member (20 to 31 points), according to the scores of Fugl-Meyer test
- comfortable walking speed on the ground between 0.3 and 1.15 m / s;
- Rating between levels 04-06 on Functional Mobility Scale (FMS) - Functional Mobility Scale and ambulate at least 50 meters
- Presentation of the AVE imaging
- Science Signature regarding the free and informed consent (WIC).
Who cannot join
- present cognitive impairment (mini mental) with scores below 24 points;
- visual impairment that may interfere with the performance of the tests;
- severe heart failure (congestive heart failure, angina, peripheral vascular disease), pacemaker use, β-blockers and propranolol;
- contraindications to the use of tDCS (brain implants of metal clips near the region to be stimulated, history of recurrent seizures, recurrent epilepsy and brain tumors, brain pacemaker and / or plates or metal devices in place of stimulation tDCS)
- irregular menstrual cycle or be in the menstrual period during the evaluation;
- No medical certificate for treadmill exercise test
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University Nove de Julho
São Paulo, São Paulo, 01504001
Glauber Heinz, Postgraduate, 5511970883072, glauber.heinz@hotmail.com
About this study
Official title: Evaluation of Autonomic Modulation in the Hemiparetic Patients After Transcranial Direct Current Stimulation (tDCS) and Treadmill Training: Clinical Trial, Controlled, a Randomized, Double-blind
Introduction: Patients post-stroke may have autonomic dysfunction, with increased blood pressure, heart rate (HR) and increased risk of sudden death. Studies have shown that transcranial direct-current stimulation (tDCS) can modulate the autonomic nervous system in healthy subjects, but little is known about these effects in stroke.
Objective: To evaluate the effect of tDCS after treadmill training in the autonomic nervous system modulation in patients post-stroke.
Read the detailed description
Introduction: Patients post-stroke may have autonomic dysfunction, with increased blood pressure, heart rate (HR) and increased risk of sudden death. Studies have shown that transcranial direct-current stimulation (tDCS) can modulate the autonomic nervous system in healthy subjects, but little is known about these effects in stroke.
Objective: To evaluate the effect of tDCS after treadmill training in the autonomic nervous system modulation in patients post-stroke.
Methods: Clinical study, crossover, controlled, randomized, double-blind individuals with hemiparesis after stroke adults. Patients will undergo a spirometric evaluation (Harbor protocol modified with constant speed, determined by the individual and the incline of the treadmill with incremented 2.5% every 2 minutes). The next day will begin with one of the two randomized protocols, one week interval between them: 1 (tDCS active and treadmill), 2 (tDCS placebo and treadmill). Each protocol will last 40 minutes (20min of tDCS over 20min mat). They will be evaluated heart rate variability (HRV) and blood pressure variability (VPA) before a minute for the protocols and in the recovery phase, for 15 minutes. 2mA current intensity, the anode electrode over the left temporal cortex and cathode on the contralateral deltoid muscle. Considering the neurophysiological effects of noninvasive techniques neuromodulators plasticity before the modulation of the autonomic nervous system, it is concluded that this study shows potential for the discovery of a new therapeutic tool in the rehabilitation of patients with stroke and hypertension. The hypothesis is that increasing the excitability of the left insular cortex, a modulation of the autonomic nervous system in controlling the variability in systolic blood pressure and heart rate is possible in conjunction with aerobic training, can provide greater hemodynamic effectiveness and decrease the time training. It is also understood that the study may have impact on the reduction of public costs spent on the rehabilitation of patients with stroke.
- Conditions
- Stroke
- Being tested
- Transcranial direct current stimulation (tDCS), training on the running belt
- Keywords
- tDCS, Stroke, Autonomic Modulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (tDCS)Device
The active tDCS and placebo will be applied to anode electrode on left temporal cortex placed on the scalp in the region T3. The cathode electrode on the middle deltoid muscle contralateral to the anode.
training on the running beltDevice
The running in the treadmill will be held on a single training session and the speed of the cardiopulmonary exercise testing and slope from 60 to 80% of the maximum achieved in cardiopulmonary testing, in order that the patient reaches 60% to 70% of the heart rate reserve.
| Study group | Role | What they receive |
|---|---|---|
| tDCS device and Treatmill | Active comparator | The stimulation is accomplished with a direct current-tDCS Stimulator Plus device, via two surface electrodes sponge (non-metallic) 5-7 cm2 in saline moistened with a 2mA current during 20 minutes after hemodinamic analysis is performed for 15 minutes and then made only training treadmill for 20 minutes. Placebo tDCS will follow the same procedures, but the tDCS device will only be switched on for 20 seconds. The running in the treadmill will be held on a single training session and the speed of the cardiopulmonary exercise testing and slope from 60 to 80% of the maximum achieved in cardiopulmonary testing, in order that the patient reaches 60% to 70% of the heart rate reserve (MACKO , 2005). Receives: Device: Transcranial direct current stimulation (tDCS); Device: training on the running belt |
| 1- tDCS | Sham comparator | 1. Who received stimulation transcranial direct current active will receive Sham stimulation and who received the placebo stimulation receive active stimulation and then the two groups will do the workout on the treadmill Receives: Device: Transcranial direct current stimulation (tDCS); Device: training on the running belt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Cardiac Frequency Variability (HRV) as measured by spectral analysis by Finomiter (FMS, Finapres Measurement Systems, Arnhem, Netherlands), in ms²
Measured: 1 years
Secondary outcomes (1)
Blood pressure variability
Blood Pressure Variability (BPV) as measured by spectral analysis by Finomiter (FMS, Finapres Measurement Systems, Arnhem, Netherlands), in mmHg
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionMay 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glauber Heinz, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956096
- Sponsor's protocol ID
- u64963ep
- Status last verified
- Sep 2016
- First submitted
- 30 Sep 2016
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Al-Qudah ZA, Yacoub HA, Souayah N. Disorders of the Autonomic Nervous System after Hemispheric Cerebrovascular Disorders: An Update. J Vasc Interv Neurol. 2015 Oct;8(4):43-52.
PubMed 26576215Verberne AJ, Owens NC. Cortical modulation of the cardiovascular system. Prog Neurobiol. 1998 Feb;54(2):149-68. doi: 10.1016/s0301-0082(97)00056-7.
PubMed 9481796Billinger SA, Arena R, Bernhardt J, Eng JJ, Franklin BA, Johnson CM, MacKay-Lyons M, Macko RF, Mead GE, Roth EJ, Shaughnessy M, Tang A; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Lifestyle and Cardiometabolic Health; Council on Epidemiology and Prevention; Council on Clinical Cardiology. Physical activity and exercise recommendations for stroke survivors: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Aug;45(8):2532-53. doi: 10.1161/STR.0000000000000022. Epub 2014 May 20.
PubMed 24846875Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PubMed 7154893Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15.
PubMed 21320389Christensen H, Boysen G, Christensen AF, Johannesen HH. Insular lesions, ECG abnormalities, and outcome in acute stroke. J Neurol Neurosurg Psychiatry. 2005 Feb;76(2):269-71. doi: 10.1136/jnnp.2004.037531.
PubMed 15654050Colivicchi F, Bassi A, Santini M, Caltagirone C. Prognostic implications of right-sided insular damage, cardiac autonomic derangement, and arrhythmias after acute ischemic stroke. Stroke. 2005 Aug;36(8):1710-5. doi: 10.1161/01.STR.0000173400.19346.bd. Epub 2005 Jul 14.
PubMed 16020766Eckardt M, Gerlach L, Welter FL. Prolongation of the frequency-corrected QT dispersion following cerebral strokes with involvement of the insula of Reil. Eur Neurol. 1999;42(4):190-3. doi: 10.1159/000008105.
PubMed 10567813Graham HK, Harvey A, Rodda J, Nattrass GR, Pirpiris M. The Functional Mobility Scale (FMS). J Pediatr Orthop. 2004 Sep-Oct;24(5):514-20. doi: 10.1097/00004694-200409000-00011.
PubMed 15308901Kang J, Hong JH, Jang MU, Kim BJ, Bae HJ, Han MK. Cardioembolism and Involvement of the Insular Cortex in Patients with Ischemic Stroke. PLoS One. 2015 Oct 21;10(10):e0139540. doi: 10.1371/journal.pone.0139540. eCollection 2015.
PubMed 26489090Kluding PM, Tseng BY, Billinger SA. Exercise and executive function in individuals with chronic stroke: a pilot study. J Neurol Phys Ther. 2011 Mar;35(1):11-7. doi: 10.1097/NPT.0b013e318208ee6c.
PubMed 21475079Macey PM, Wu P, Kumar R, Ogren JA, Richardson HL, Woo MA, Harper RM. Differential responses of the insular cortex gyri to autonomic challenges. Auton Neurosci. 2012 May 21;168(1-2):72-81. doi: 10.1016/j.autneu.2012.01.009. Epub 2012 Feb 17.
PubMed 22342370Macko RF, Ivey FM, Forrester LW, Hanley D, Sorkin JD, Katzel LI, Silver KH, Goldberg AP. Treadmill exercise rehabilitation improves ambulatory function and cardiovascular fitness in patients with chronic stroke: a randomized, controlled trial. Stroke. 2005 Oct;36(10):2206-11. doi: 10.1161/01.STR.0000181076.91805.89. Epub 2005 Sep 8.
PubMed 16151035Makovac E, Thayer JF, Ottaviani C. A meta-analysis of non-invasive brain stimulation and autonomic functioning: Implications for brain-heart pathways to cardiovascular disease. Neurosci Biobehav Rev. 2017 Mar;74(Pt B):330-341. doi: 10.1016/j.neubiorev.2016.05.001. Epub 2016 May 13.
PubMed 27185286Pang MY, Eng JJ, Dawson AS, Gylfadottir S. The use of aerobic exercise training in improving aerobic capacity in individuals with stroke: a meta-analysis. Clin Rehabil. 2006 Feb;20(2):97-111. doi: 10.1191/0269215506cr926oa.
PubMed 16541930
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Autonomic Modulation in the Hemiparetic Patients After Transcranial Direct Current Stimulation (tDCS) and Treadmill Training: Clinical Trial, Controlled, a Randomized, Double-blind
- ClinicalTrials.gov ID
- NCT02956096
- Acronym / sponsor ID
- u64963ep
- Conditions
- Stroke
- Keywords
- tDCS, Stroke, Autonomic Modulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 4 Nov 2016 (estimated)
- 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.
Introduction: Patients post-stroke may have autonomic dysfunction, with increased blood pressure, heart rate (HR) and increased risk of sudden death. Studies have shown that transcranial direct-current stimulation (tDCS) can modulate the autonomic nervous system in healthy subjects, but little is known about these effects in stroke.
Objective: To evaluate the effect of tDCS after treadmill training in the autonomic nervous system modulation in patients post-stroke.
Detailed description
Introduction: Patients post-stroke may have autonomic dysfunction, with increased blood pressure, heart rate (HR) and increased risk of sudden death. Studies have shown that transcranial direct-current stimulation (tDCS) can modulate the autonomic nervous system in healthy subjects, but little is known about these effects in stroke.
Objective: To evaluate the effect of tDCS after treadmill training in the autonomic nervous system modulation in patients post-stroke.
Methods: Clinical study, crossover, controlled, randomized, double-blind individuals with hemiparesis after stroke adults. Patients will undergo a spirometric evaluation (Harbor protocol modified with constant speed, determined by the individual and the incline of the treadmill with incremented 2.5% every 2 minutes). The next day will begin with one of the two randomized protocols, one week interval between them: 1 (tDCS active and treadmill), 2 (tDCS placebo and treadmill). Each protocol will last 40 minutes (20min of tDCS over 20min mat). They will be evaluated heart rate variability (HRV) and blood pressure variability (VPA) before a minute for the protocols and in the recovery phase, for 15 minutes. 2mA current intensity, the anode electrode over the left temporal cortex and cathode on the contralateral deltoid muscle. Considering the neurophysiological effects of noninvasive techniques neuromodulators plasticity before the modulation of the autonomic nervous system, it is concluded that this study shows potential for the discovery of a new therapeutic tool in the rehabilitation of patients with stroke and hypertension. The hypothesis is that increasing the excitability of the left insular cortex, a modulation of the autonomic nervous system in controlling the variability in systolic blood pressure and heart rate is possible in conjunction with aerobic training, can provide greater hemodynamic effectiveness and decrease the time training. It is also understood that the study may have impact on the reduction of public costs spent on the rehabilitation of patients with stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS device and Treatmill | Active comparator | Device: Transcranial direct current stimulation (tDCS), Device: training on the running beltThe stimulation is accomplished with a direct current-tDCS Stimulator Plus device, via two surface electrodes sponge (non-metallic) 5-7 cm2 in saline moistened with a 2mA current during 20 minutes after hemodinamic analysis is performed for 15 minutes and then made only training treadmill for 20 minutes. Placebo tDCS will follow the same procedures, but the tDCS device will only be switched on for 20 seconds. The running in the treadmill will be held on a single training session and the speed of the cardiopulmonary exercise testing and slope from 60 to 80% of the maximum achieved in cardiopulmonary testing, in order that the patient reaches 60% to 70% of the heart rate reserve (MACKO , 2005). |
| 1- tDCS | Sham comparator | Device: Transcranial direct current stimulation (tDCS), Device: training on the running belt1. Who received stimulation transcranial direct current active will receive Sham stimulation and who received the placebo stimulation receive active stimulation and then the two groups will do the workout on the treadmill |
Who may qualify
- Ages
- 21 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- present hemiparesis due to stroke for more than 6 months;
- Commitment mild or moderate motor in the lower member (20 to 31 points), according to the scores of Fugl-Meyer test
- comfortable walking speed on the ground between 0.3 and 1.15 m / s;
- Rating between levels 04-06 on Functional Mobility Scale (FMS) - Functional Mobility Scale and ambulate at least 50 meters
- Presentation of the AVE imaging
Key exclusion criteria (6 listed)
- present cognitive impairment (mini mental) with scores below 24 points;
- visual impairment that may interfere with the performance of the tests;
- severe heart failure (congestive heart failure, angina, peripheral vascular disease), pacemaker use, β-blockers and propranolol;
- contraindications to the use of tDCS (brain implants of metal clips near the region to be stimulated, history of recurrent seizures, recurrent epilepsy and brain tumors, brain pacemaker and / or plates or metal devices in place of stimulation tDCS)
- irregular menstrual cycle or be in the menstrual period during the evaluation;
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 |
|---|---|---|
| Transcranial direct current stimulation (tDCS)The active tDCS and placebo will be applied to anode electrode on left temporal cortex placed on the scalp in the region T3. The cathode electrode on the middle deltoid muscle contralateral to the anode. | Device | 1- tDCS, tDCS device and Treatmill |
| training on the running beltThe running in the treadmill will be held on a single training session and the speed of the cardiopulmonary exercise testing and slope from 60 to 80% of the maximum achieved in cardiopulmonary testing, in order that the patient reaches 60% to 70% of the heart rate reserve. | Device | 1- tDCS, tDCS device and Treatmill |
Primary outcome
Heart rate variability
Time frame: 1 years
Cardiac Frequency Variability (HRV) as measured by spectral analysis by Finomiter (FMS, Finapres Measurement Systems, Arnhem, Netherlands), in ms²
1 secondary outcome
Blood pressure variability
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
- Background: PubMed 26576215Al-Qudah ZA, Yacoub HA, Souayah N. Disorders of the Autonomic Nervous System after Hemispheric Cerebrovascular Disorders: An Update. J Vasc Interv Neurol. 2015 Oct;8(4):43-52.
- Background: PubMed 9481796Verberne AJ, Owens NC. Cortical modulation of the cardiovascular system. Prog Neurobiol. 1998 Feb;54(2):149-68. doi: 10.1016/s0301-0082(97)00056-7.
- Background: PubMed 24846875Billinger SA, Arena R, Bernhardt J, Eng JJ, Franklin BA, Johnson CM, MacKay-Lyons M, Macko RF, Mead GE, Roth EJ, Shaughnessy M, Tang A; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Lifestyle and Cardiometabolic Health; Council on Epidemiology and Prevention; Council on Clinical Cardiology. Physical activity and exercise recommendations for stroke survivors: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Aug;45(8):2532-53. doi: 10.1161/STR.0000000000000022. Epub 2014 May 20.
- Background: PubMed 7154893Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- Background: PubMed 21320389Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15.
- Background: PubMed 15654050Christensen H, Boysen G, Christensen AF, Johannesen HH. Insular lesions, ECG abnormalities, and outcome in acute stroke. J Neurol Neurosurg Psychiatry. 2005 Feb;76(2):269-71. doi: 10.1136/jnnp.2004.037531.
- Background: PubMed 16020766Colivicchi F, Bassi A, Santini M, Caltagirone C. Prognostic implications of right-sided insular damage, cardiac autonomic derangement, and arrhythmias after acute ischemic stroke. Stroke. 2005 Aug;36(8):1710-5. doi: 10.1161/01.STR.0000173400.19346.bd. Epub 2005 Jul 14.
- Background: PubMed 10567813Eckardt M, Gerlach L, Welter FL. Prolongation of the frequency-corrected QT dispersion following cerebral strokes with involvement of the insula of Reil. Eur Neurol. 1999;42(4):190-3. doi: 10.1159/000008105.
- Background: PubMed 15308901Graham HK, Harvey A, Rodda J, Nattrass GR, Pirpiris M. The Functional Mobility Scale (FMS). J Pediatr Orthop. 2004 Sep-Oct;24(5):514-20. doi: 10.1097/00004694-200409000-00011.
- Background: PubMed 26489090Kang J, Hong JH, Jang MU, Kim BJ, Bae HJ, Han MK. Cardioembolism and Involvement of the Insular Cortex in Patients with Ischemic Stroke. PLoS One. 2015 Oct 21;10(10):e0139540. doi: 10.1371/journal.pone.0139540. eCollection 2015.
- Background: PubMed 21475079Kluding PM, Tseng BY, Billinger SA. Exercise and executive function in individuals with chronic stroke: a pilot study. J Neurol Phys Ther. 2011 Mar;35(1):11-7. doi: 10.1097/NPT.0b013e318208ee6c.
- Background: PubMed 22342370Macey PM, Wu P, Kumar R, Ogren JA, Richardson HL, Woo MA, Harper RM. Differential responses of the insular cortex gyri to autonomic challenges. Auton Neurosci. 2012 May 21;168(1-2):72-81. doi: 10.1016/j.autneu.2012.01.009. Epub 2012 Feb 17.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation (tDCS) and training on the running belt in people with Stroke, run by University of Nove de Julho 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 6 inclusion and 6 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 23 Nov 2016. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Glauber Heinz, Postgraduate (5511970883072, glauber.heinz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (time frame: 1 years). 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 NCT02956096, which also lists 33 linked publications.
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 23 Nov 2016.