Hot FlashesNCT01896791
Transcranial Direct Current Stimulation (tDCS) in Vasomotor Symptoms of Menopause
A study testing Transcranial Direct Current Stimulation in people with Hot Flashes, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Climacteric or Menopausal Transition is defined as the time period where there is a change to non-reproductive reproductive life, with extension of variable length. During this period, and after the establishment of Menopause and non-functioning ovarian, the appearance of various symptoms that express the depletion of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hot Flashes
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2013to Aug 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- menopause women, any age, with at least, eight hot flashes/day
Who cannot join
- neurological or psychiatric diseases, patients with head injury, women in hormonal replacement
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
About this study
Official title: Transcranial Direct Current Stimulation (tDCS) in Vasomotor Symptoms of Menopause: Blind Sham Controlled Randomized Clinical Trial
Climacteric or Menopausal Transition is defined as the time period where there is a change to non-reproductive reproductive life, with extension of variable length. During this period, and after the establishment of Menopause and non-functioning ovarian, the appearance of various symptoms that express the depletion of ovarian follicles is common; among these symptoms, the most frequently reported by women are vasomotor symptoms or hot flashes. In addition to hormonal therapy, other medications have been employed in an attempt to improve these symptoms; although they present better results than placebo, yet have little clinical impact in reducing vasomotor symptoms. Therefore, this gap allows the evaluation of alternative therapies, such as Transcranial Direct Current Stimulation (tDCS). The rationale for studying the effect of this technique in this context is its possible autonomic modulatory effect. What reinforces the choice of this technique is the fact that it demonstrated efficacy in other pathologies such as depression, pain, Parkinson's disease, among others. Transcranial direct current stimulation (tDCS) is a renewed method of non-invasive brain modulation. It is based on a transcranial application of weak direct currents in a non-invasive, simple and painless manner. Its use in the treatment of vasomotor symptoms has not been studied. The objective of this study is to evaluate the improvement of vasomotor symptoms in postmenopausal women, after application of tDCS, and compare them to a control group. This Randomized Clinical Trial will be held in female postmenopausal patients, followed in the outpatient Menopause Clinic of Obstetrics and Gynecology Service, Hospital de Clinicas de Porto Alegre. From these results, it is expected to present a new therapeutic option in the treatment of vasomotor symptoms.
Read the detailed description
Primary Outcome: evaluate the effect of tDCS on vasomotor symptoms in postmenopausal women treated at a tertiary hospital in southern Brazil.
Secondary Outcome: compare the effect of tDCS with sham-tDCS in postmenopausal women on vasomotor symptoms, FSH (Follicle Stimulating Hormone) levels, salivary cortisol, BDNF (Brains derived neurotrophic factor)levels,depressive symptoms and quality of life.
Interventions:
- Application of tDCS for a period of 10 consecutive days.
- Transcranial direct current stimulation (tDCS):
Active stimulation: the anode electrode is placed in the area of the motor cortex M1 C3 or C4 position of the dominant hemisphere (International 10-20 EEG System). The cathode electrode is placed over the contralateral supraorbital region to the anode electrode. Treatment time and intensity of the stimulus: 2 mili Ampere, 20min, 10 days.
Placebo-sham: appliance off during the entire period without active stimulation, with the position of the electrodes in the same sites of active stimulation.
The placebo group do not receive pharmacological treatment or other during the research.
After treatment, patients will be reassessed in a week, a month and three months with new application of questionnaires and sample collection.
- Conditions
- Hot Flashes
- Being tested
- Transcranial Direct Current Stimulation, Sham Stimulation
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationProcedure or surgery
Active Transcranial Direct Current Stimulation : the anode electrode is placed in the area of the motor cortex M1 C3 or C4 position of the dominant hemisphere (International 10-20 EEG System). The cathode electrode is placed over the contralateral supraorbital region to the anode electrode. Treatment time and intensity of the stimulus: tDCS: 2 mili Ampere, 20min, 10 days.
Sham StimulationProcedure or surgery
Sham Stimulation- appliance off during the entire period without active stimulation, with the position of the electrodes in the same sites of active stimulation
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Direct Current Stimulation | Active comparator | Active Transcranial Direct Current Stimulation: the anode electrode is placed in the area of the motor cortex M1 C3 or C4 position of the dominant hemisphere (International 10-20 EEG System). The cathode electrode is placed over the contralateral supraorbital region to the anode electrode. Treatment time and intensity of the stimulus: tDCS: 2mili Ampere, 20min, 10 days. Receives: Procedure: Transcranial Direct Current Stimulation |
| Sham Stimulation | Placebo comparator | Sham Stimulation: appliance off during the entire period without active stimulation, with the position of the electrodes in the same sites of active stimulation Receives: Procedure: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of diary vasomotor symptoms
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Celeste Wender, PhD, Principal investigator, Hospítal de Clinicas de Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896791
- Sponsor's protocol ID
- 12-0418
- Status last verified
- Feb 2018
- First submitted
- 8 Jul 2013
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) in Vasomotor Symptoms of Menopause: Blind Sham Controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01896791
- Acronym / sponsor ID
- 12-0418
- Conditions
- Hot Flashes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 11 Jul 2013 (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.
Climacteric or Menopausal Transition is defined as the time period where there is a change to non-reproductive reproductive life, with extension of variable length. During this period, and after the establishment of Menopause and non-functioning ovarian, the appearance of various symptoms that express the depletion of ovarian follicles is common; among these symptoms, the most frequently reported by women are vasomotor symptoms or hot flashes. In addition to hormonal therapy, other medications have been employed in an attempt to improve these symptoms; although they present better results than placebo, yet have little clinical impact in reducing vasomotor symptoms. Therefore, this gap allows the evaluation of alternative therapies, such as Transcranial Direct Current Stimulation (tDCS). The rationale for studying the effect of this technique in this context is its possible autonomic modulatory effect. What reinforces the choice of this technique is the fact that it demonstrated efficacy in other pathologies such as depression, pain, Parkinson's disease, among others. Transcranial direct current stimulation (tDCS) is a renewed method of non-invasive brain modulation. It is based on a transcranial application of weak direct currents in a non-invasive, simple and painless manner. Its use in the treatment of vasomotor symptoms has not been studied. The objective of this study is to evaluate the improvement of vasomotor symptoms in postmenopausal women, after application of tDCS, and compare them to a control group. This Randomized Clinical Trial will be held in female postmenopausal patients, followed in the outpatient Menopause Clinic of Obstetrics and Gynecology Service, Hospital de Clinicas de Porto Alegre. From these results, it is expected to present a new therapeutic option in the treatment of vasomotor symptoms.
Detailed description
Primary Outcome: evaluate the effect of tDCS on vasomotor symptoms in postmenopausal women treated at a tertiary hospital in southern Brazil.
Secondary Outcome: compare the effect of tDCS with sham-tDCS in postmenopausal women on vasomotor symptoms, FSH (Follicle Stimulating Hormone) levels, salivary cortisol, BDNF (Brains derived neurotrophic factor)levels,depressive symptoms and quality of life.
Interventions:
- Application of tDCS for a period of 10 consecutive days.
- Transcranial direct current stimulation (tDCS):
Active stimulation: the anode electrode is placed in the area of the motor cortex M1 C3 or C4 position of the dominant hemisphere (International 10-20 EEG System). The cathode electrode is placed over the contralateral supraorbital region to the anode electrode. Treatment time and intensity of the stimulus: 2 mili Ampere, 20min, 10 days.
Placebo-sham: appliance off during the entire period without active stimulation, with the position of the electrodes in the same sites of active stimulation.
The placebo group do not receive pharmacological treatment or other during the research.
After treatment, patients will be reassessed in a week, a month and three months with new application of questionnaires and sample collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Direct Current Stimulation | Active comparator | Procedure: Transcranial Direct Current StimulationActive Transcranial Direct Current Stimulation: the anode electrode is placed in the area of the motor cortex M1 C3 or C4 position of the dominant hemisphere (International 10-20 EEG System). The cathode electrode is placed over the contralateral supraorbital region to the anode electrode. Treatment time and intensity of the stimulus: tDCS: 2mili Ampere, 20min, 10 days. |
| Sham Stimulation | Placebo comparator | Procedure: Sham StimulationSham Stimulation: appliance off during the entire period without active stimulation, with the position of the electrodes in the same sites of active stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- menopause women, any age, with at least, eight hot flashes/day
Key exclusion criteria (1 listed)
- neurological or psychiatric diseases, patients with head injury, women in hormonal replacement
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 StimulationActive Transcranial Direct Current Stimulation : the anode electrode is placed in the area of the motor cortex M1 C3 or C4 position of the dominant hemisphere (International 10-20 EEG System). The cathode electrode is placed over the contralateral supraorbital region to the anode electrode. Treatment time and intensity of the stimulus: tDCS: 2 mili Ampere, 20min, 10 days. | Procedure or surgery | Transcranial Direct Current Stimulation |
| Sham StimulationSham Stimulation- appliance off during the entire period without active stimulation, with the position of the electrodes in the same sites of active stimulation | Procedure or surgery | Sham Stimulation |
Primary outcome
number of diary vasomotor symptoms
Time frame: 30 days
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 1 Mar 2018.
- 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.
Maria Celeste Wender, PhD principal investigator
Hospítal de Clinicas de Professor
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 in people with Hot Flashes, run by Hospital de Clinicas de Porto Alegre 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 1 inclusion and 1 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 1 Mar 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. 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?
number of diary vasomotor symptoms (time frame: 30 days). 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 1 Mar 2018.