- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03594916
Efficacy of Transcranial Direct Current Stimulation for Severe Primary Dysmenorrhea
February 11, 2019 updated by: Taipei Veterans General Hospital, Taiwan
Efficacy of Transcranial Direct Current Stimulation for Severe Refractory Primary Dysmenorrhea: Translational and Genetic Neuroimaging Studies
Primary Dysmenorrhea (PDM), defined as menstrual pain without discernable organic causes, is inexorably common in adolescent women, about 40-90% of women may suffer from it, and 20% of them can be severe in the context of being refractory to medication, daily function impairment, and having pain of severe degree.
Novel therapeutic method is in need for pain alleviation for this particular phenotype.
We have previously reported that PDM females may engage motor-cortex based descending pain modulation system in our resting-state functional Magnetic Resonance Imaging (rs-fMRI) and thermal pain-activation fMRI studies.
Based on the reported analgesic efficacy of transcranial Direct Current Stimulation (tDCS) on the motor cortex for various experimental painful conditions and clinical pain disorders, we reason that tDCS can be effective for the severe and medication-refractory PDM patients.
This study aim to investigate the analgesic efficacy of tDCS in severe PDMs and to elucidate the dynamic brain neuroplasticity in the context of functional connectivity (FC) of pain matrix after tDCS intervention.
We will recruit 30 severe PDMs and randomly allocate them to either real or sham group in a triple-blind manner.
rs-fMRI for functional connectivity analysis will be performed before and after the tDCS intervention.
The imaging data will be correlated with behavioral and psychological measurements.
This is the first study in the literature investigating the tDCS efficacy for severe PDM.
The result can promise a new possibility for clinical application.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan, 112
- Taipei Veterans General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 20-35 years old PDM patients
- Right-handedness
- A regular menstrual cycle: 27-32 days
- Cramping pain during the menstrual period in the last 6 months , VAS ≧ 7
- Abstinence for daily activities due to PDM
- Need analgesic or Physical therapy despite of no prominent effect
Exclusion Criteria:
- History of head injury
- Pathological pituitary gland disease
- Organic pelvic disease, psychiatric disorder
- Pregnancy, childbirth
- A metal or pacemaker implant.
- Take hormone agents within 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active tDCS
The anode sponge electrode will be placed on the scalp over the left primary motor cortex (M1) and the cathode sponge electrode will be positioned over the right supraorbital cortex (SO).
Active stimulation consists of 2 mA current applied continuously for 20 minutes.
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The anode and cathode sponge electrode (51 cm2) will be placed over C3 and FP2 (10-20 system) respectively.
2 mA current will be applied continuously for 20 minutes.
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Sham Comparator: Sham tDCS
The anode sponge electrode will be placed on the scalp over the left primary motor cortex (M1) and the cathode sponge electrode will be positioned over the right supraorbital cortex (SO).
The 2 mA current will be applied for 30 seconds at the beginning of the session.
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The anode and cathode sponge electrode (51 cm2) will be placed over C3 and FP2 (10-20 system) respectively.
2 mA current will be applied for 30 seconds at the beginning.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS)
Time Frame: change from baseline (1st menstrual phase, before tDCS) at one month (2nd menstrual phase, with tDCS), change from baseline (1st menstrual phase, before tDCS) at two months (3rd menstrual phase)
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pain scale; from 0 to 10; score 0: no pain, score 10: unbearable pain
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change from baseline (1st menstrual phase, before tDCS) at one month (2nd menstrual phase, with tDCS), change from baseline (1st menstrual phase, before tDCS) at two months (3rd menstrual phase)
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Functional connectivity of rs-fMRI Imaging
Time Frame: change from baseline (before tDCS, before 2nd menstrual phase) at one week (after tDCS completion), change from baseline (before tDCS, before 2nd menstrual phase) at four weeks (before the 3rd menstrual phase)
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Resting-state functional magnetic resonance imaging (rs-fMRI) is a well established method of functional magnetic resonance imaging (fMRI) that is used to evaluate regional interactions in the brain that occur in a resting (task-negative) state, when a subject is not performing an explicit task.
Functional connectivity is the connectivity between brain regions that share functional properties, it can be defined as the correlation between spatially remote neurophysiological events, expressed as the neural networks of brain.
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change from baseline (before tDCS, before 2nd menstrual phase) at one week (after tDCS completion), change from baseline (before tDCS, before 2nd menstrual phase) at four weeks (before the 3rd menstrual phase)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantitative sensory testing (QST)
Time Frame: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)
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To assess the threshold of thermal sensation (cold, cold-pain, heat, heat-pain; from 0 to 50 centigrade temperature), according to the established protocol of an ascending limit approach for heat pain and a descending limit approach for cold pain.
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change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)
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Spielberger State-Trait Anxiety Inventory (STAI)
Time Frame: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)
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To assess anxious symptoms; from 20 to 80; score 20: not anxious, score 80: extremely anxious
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change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)
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Beck Anxiety Inventory (BAI)
Time Frame: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)
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To assess anxious symptoms; from 0 to 63; score 0: not anxious, score 63: extremely anxious
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change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)
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Beck Depression Inventory (BDI)
Time Frame: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)
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To assess depressive symptoms; from 0 to 63; score 0: not depressed, score 63: extremely depressed
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change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)
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Pain Catastrophizing Scale (PCS)
Time Frame: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)
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To assess pain-maladaptive psychological status; from 0 to 52; score 0: not pain Catastrophizing , score 52: extremely pain Catastrophizing
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change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)
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Long-form McGill Pain Questionnaire (MPQ)
Time Frame: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)
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To assess pain status; from 0 to 78; score 0: not painful, score 78: extremely painful
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change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)
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Short-Form Health Survey (SF-36)
Time Frame: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)
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To assess quality of life; he SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
From 0 to 100; score 0: equivalent to maximum disability, score 100: no disability.
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change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)
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Blood Hormones Measurement
Time Frame: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase)
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To assess testosterone, progesterone, estrogen
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change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase)
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Genotyping
Time Frame: baseline
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To genotype the single nucleotide polymorphism genotyping (i.e., BDNF Val66Met polymorphism (rs6265), COMT Val158Met polymorphism (rs4680), OPRM1 (rs1799971), 5HTR2A (rs6313), SLC6A4 (rs25531)) from blood specimen
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baseline
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Efficacy of tDCS blinding
Time Frame: At 1 months after tDCS intervention
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To assure blinding efficacy; Patients do self-assessment about whether they receive real tDCS or sham tDCS.
Assessment questionnaire:1 or 0. 1: real tDCS; 0: sham tDCS.
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At 1 months after tDCS intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 8, 2015
Primary Completion (Actual)
November 30, 2018
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
May 21, 2018
First Submitted That Met QC Criteria
July 11, 2018
First Posted (Actual)
July 20, 2018
Study Record Updates
Last Update Posted (Actual)
February 15, 2019
Last Update Submitted That Met QC Criteria
February 11, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-01-004A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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