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

NCT01896791 | Completed

• 1 other identifier: 12-0418
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hot Flashes

Outcome Measures

Primary Outcomes (1)

• number of diary vasomotor symptoms

  30 days

Study Arms (2)

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.

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

Procedure: Sham Stimulation

Interventions

Transcranial Direct Current Stimulation PROCEDURE

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.

Transcranial Direct Current Stimulation

Sham Stimulation PROCEDURE

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

Sham Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Hot Flashes

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Maria Celeste Wender, PhD

  Hospítal de Clinicas de Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: July 11, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2017
• Last Updated: March 1, 2018

Record last verified: 2018-02

Locations

BR (1)