NCT01143636

Transcranial Direct Stimulation in Chronic Pelvic Pain

Investigation and Treatment of Central Nervous System Dysfunction in Chronic Pelvic Pain.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Spaulding Rehabilitation Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) is effective in reducing pain in subjects with chronic pelvic pain. Our hypothesis is that tDCS will decrease pain significantly when compared to sham stimulation.

Detailed description

The study encompasses two experiments: The first one involves patients with chronic pain, receiving 10 sessions of stimulation, active or sham (parallel design). The second experiment involves involves healthy subjects, receiving active or sham tDCS over the primary motor cortex (crossover design).

Conditions

• Pelvic Pain
• Healthy

Interventions

Type	Name	Description
DEVICE	Transcranial Direct Current Stimulation	Chronic pain subjects will be randomized to receive either active or sham stimulation for the duration of the trial. The subject will receive 10 consecutive sessions at an intensity of 2mA with each session lasting 20 minutes. If the subject receives active stimulation the current will be applied for the full 20 minutes, while in the sham group current will only be applied for 30 seconds. In the healthy cohort, subjects will receive one session of active stimulation and one session of sham stimulation. The parameters will be the same as the pain subjects, at an intensity of 2mA for 20 minutes.

Timeline

• Start date: 2010-04-01
• Primary completion: 2012-12-01
• Completion: 2013-05-01
• First posted: 2010-06-14
• Last updated: 2020-04-24
• Results posted: 2017-03-15

Locations

1 site across 1 country: United States