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

NCT ID: NCT03608215

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-08
• Study Completion Date: 2018-12-31

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.

Conditions

Primary Dysmenorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Active tDCS

Intervention Type: DEVICE

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 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.

Group Type: SHAM_COMPARATOR

Sham tDCS

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

2015-01-005B

Identifier Type: -

Identifier Source: org_study_id