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Efficacy of Transcranial Direct Current Stimulation for Severe Primary Dysmenorrhea

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ClinicalTrials.gov Identifier: NCT03594916
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Primary Dysmenorrhea Device: Active tDCS Device: Sham tDCS Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: active, sham
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Transcranial Direct Current Stimulation for Severe Refractory Primary Dysmenorrhea: Translational and Genetic Neuroimaging Studies
Actual Study Start Date : September 8, 2015
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain

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.
Device: Active tDCS
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.

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.
Device: Sham tDCS
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.




Primary Outcome Measures :
  1. 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) ]
    pain scale; from 0 to 10; score 0: no pain, score 10: unbearable pain

  2. 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) ]
    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.


Secondary Outcome Measures :
  1. 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) ]
    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.

  2. 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) ]
    To assess anxious symptoms; from 20 to 80; score 20: not anxious, score 80: extremely anxious

  3. 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) ]
    To assess anxious symptoms; from 0 to 63; score 0: not anxious, score 63: extremely anxious

  4. 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) ]
    To assess depressive symptoms; from 0 to 63; score 0: not depressed, score 63: extremely depressed

  5. 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) ]
    To assess pain-maladaptive psychological status; from 0 to 52; score 0: not pain Catastrophizing , score 52: extremely pain Catastrophizing

  6. 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) ]
    To assess pain status; from 0 to 78; score 0: not painful, score 78: extremely painful

  7. 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) ]
    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.

  8. 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) ]
    To assess testosterone, progesterone, estrogen

  9. Genotyping [ Time Frame: baseline ]
    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

  10. Efficacy of tDCS blinding [ Time Frame: At 1 months after tDCS intervention ]
    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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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594916


Contacts
Contact: Jen-Chuen Hsieh, MD, PhD +886-2-28757480 jchsieh@vghtpe.gov.tw

Locations
Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 112
Contact: Jen-Chuen Hsieh, MD, PhD    +886-2-28757480    jchsieh@vghtpe.gov.tw   
Principal Investigator: Jen-Chuen Hsieh, MD, PhD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan

Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03594916     History of Changes
Other Study ID Numbers: 2015-01-004A
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Taipei Veterans General Hospital, Taiwan:
Dysmenorrhea
Neuromodulation
Transcranial direct current stimulation
Neuroimaging
Neuroplasticity

Additional relevant MeSH terms:
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms