NCT03594916

Efficacy of Transcranial Direct Current Stimulation for Severe Primary Dysmenorrhea

Completed NA Last updated 15 February 2019

What this trial tests

NA trial testing Active tDCS in Primary Dysmenorrhea in 31 participants. Completed in 31 December 2018.

Timeline

8 September 2015

Primary endpoint
30 November 2018

31 December 2018

Quick facts

Lead sponsor	Taipei Veterans General Hospital, Taiwan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	31
Start date	8 September 2015
Primary completion	30 November 2018
Estimated completion	31 December 2018
Sites	1 location across Taiwan

Drugs / interventions tested

• Active tDCS
• Sham tDCS

Conditions studied

• Primary Dysmenorrhea — all drugs for Primary Dysmenorrhea →

Sponsor

Taipei Veterans General Hospital, Taiwan

Who can join

Adults 20 to 35, female only, with Primary Dysmenorrhea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.