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Transcranial Direct Current Stimulation (tDCS) in Vasomotor Symptoms of Menopause

Transcranial Direct Current Stimulation (tDCS) in Vasomotor Symptoms of Menopause: Blind Sham Controlled Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01896791
Enrollment
30
Registered
2013-07-11
Start date
2013-07-31
Completion date
2017-08-31
Last updated
2018-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hot Flashes

Brief 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 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.

Interventions

PROCEDURETranscranial Direct Current Stimulation

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.

PROCEDURESham Stimulation

Sham Stimulation- appliance off during the entire period without active stimulation, with the position of the electrodes in the same sites of active stimulation

Sponsors

Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

menopause women, any age, with at least, eight hot flashes/day

Exclusion criteria

neurological or psychiatric diseases, patients with head injury, women in hormonal replacement

Design outcomes

Primary

MeasureTime frame
number of diary vasomotor symptoms30 days

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026