Neuromodulation Effect of Transcranial Direct Current Stimulation in Severe Refractory Primary Dysmenorrhea: BDNF and MEG Study

Neuromodulatary Efficacy of Transcranial Direct Current Stimulation in Severe Refractory Primary Dysmenorrhea

Sponsors

Lead sponsor: Taipei Veterans General Hospital, Taiwan

Source 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. It has been 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, it is plausible 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 experimental pain after tDCS intervention. Thirty severe PDMs will be recruited and randomly allocated to either real or sham group in a triple-blind manner. Experimental pain electrical stimulation will be performed before and after the tDCS intervention. The experimental pain-evoked magnetoencephamographic (MEG) data will be correlated with behavioral and psychological measurements. This is the first study in the literature investigating the tDCS efficacy for acute pain in severe PDM. The result can promise a new possibility for clinical application.

Overall Status Completed
Start Date September 8, 2015
Completion Date December 31, 2018
Primary Completion Date December 31, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Visual Analog Scale (VAS) 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)
Somatosensory evoked magnetic fields to experimental pain 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)
Secondary Outcome
Measure Time Frame
Quantitative sensory testing (QST) 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)
Spielberger State-Trait Anxiety Inventory (STAI) 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)
Beck Anxiety Inventory (BAI) 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)
Beck Depression Inventory (BDI) 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)
Pain Catastrophizing Scale (PCS) 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)
Long-form McGill Pain Questionnaire (MPQ) 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)
Short-Form Health Survey (SF-36) change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)
Blood Hormones Measurement change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase)
Genotyping baseline
Efficacy of tDCS blinding At 1 months after tDCS intervention
Enrollment 31
Condition
Intervention

Intervention type: Device

Intervention name: Active tDCS

Description: 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.

Arm group label: Active tDCS

Intervention type: Device

Intervention name: Sham tDCS

Description: 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.

Arm group label: Sham tDCS

Eligibility

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

Gender: Female

Minimum age: 20 Years

Maximum age: 35 Years

Healthy volunteers: No

Location
facility Taipei Veterans General Hospital
Location Countries

Taiwan

Verification Date

February 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Active tDCS

Arm group type: Experimental

Description: 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.

Arm group label: Sham tDCS

Arm group type: Sham Comparator

Description: 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.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: active, sham

Primary purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov