Transcranial Direct Stimulation in Chronic Pelvic Pain

NCT01143636 | Completed Phase 2 Results

• 1 other identifier: 2009-P-002048
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Pain; Healthy

Keywords

Transcranial direct current stimulation; Chronic Pelvic Pain

Outcome Measures

Primary Outcomes (2)

• Pain Assessment

  We use the Visual analogue scale (VAS) to measure pain. The VAS is ranged from 0 to 10, with 0 reffering to no pain and 10 reffering the the worst possible pain. We used the difference between post treatment minus baseline to compare the two treatments (active versus sham tDCS).

  baseline and at 2 weeks

• Pressure Pain Threshold

  Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain. The change in pressure pain threshold (post minus pre intervention) is use for the analysis.

  baseline and at 2 weeks

Secondary Outcomes (9)

• Quality of Life Scale (QOLS)

  2 weeks

• Clinical Global Impression - CGI

  2 weeks

• Visual Analogue Scale - Anxiety.This Scale Measures Patients' Level of Anxiety on a Scale (0-no Anxiety to 10-worst Anxiety Ever). It Was Performed at the End of the Treatment and Compared Between the 2 Groups (Real and Sham) in Patients With Pelvic Pain

  2 weeks

• Mini Mental Scale - MMS

  2 weeks

• Beck Depression Inventory - BDI.

  2 weeks

Study Arms (4)

Active tDCS - pelvic pain patients

SHAM COMPARATOR

ACTIVE tDCS: Subjects will receive a total of 10 consecutive sessions of active tDCS over a two-week period (administered Monday - Friday). During each session, the anode electrode will be placed over the primary motor cortex of the predominantly painful side.

Device: Transcranial Direct Current Stimulation

Sham tDCS - pelvic pain patients

EXPERIMENTAL

SHAM tDCS: Subjects will receive a total of 10 consecutive sessions of sham tDCS over a two-week period (administered Mon-Fri). During each session, the anode will be placed over the primary motor cortex of the predominantly painful side.

Device: Transcranial Direct Current Stimulation

Active tDCS - healthy

EXPERIMENTAL

The healthy controls will undergo one day of treatment with active tDCS. All participants will receive both active and sham stimulation in a randomized order.

Device: Transcranial Direct Current Stimulation

Sham tDCS - healthy

EXPERIMENTAL

The healthy controls will undergo one day of treatment with sham tDCS. All participants will receive both active and sham stimulation in a randomized order.

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

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.

Also known as: tDCS, electrical stimulation

Active tDCS - healthy; Active tDCS - pelvic pain patients; Sham tDCS - healthy; Sham tDCS - pelvic pain patients

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Providing informed consent to participate in the study
• to 64 years old
• Having symptoms of pelvic pain for more than 6 months with an average of 3 on a 0-10 VAS scale (for pelvic pain subjects only)
• No history of or current genitourinary tuberculosis as self reported
• No history of urethral cancer as self reported
• No history or current bladder malignancy, high grade dysplasia or carcinoma in situ as self reported
• No occurrence of ovarian, vaginal or cervical cancer in the previous 3 years as self reported
• No current vaginal infection as self reported
• No active herpes in previous 3 months as self reported
• No antimicrobials for urinary tract infections in previous 3 months as self reported
• Never treated with cyclophosphamide as self reported
• No radiation cystitis as self reported
• No neurogenic bladder dysfunction (due to a spinal cord injury, stroke, Parkinson's disease, multiple sclerosis, spina bifida or diabetic cystopathy) as self reported
• Absence of bladder, ureteral or urethral calculi for previous 3 months as self reported
• No urethritis for previous 3 months as self reported

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Pelvic Pain

Interventions

Transcranial Direct Current Stimulation; Electric Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Physical Stimulation; Investigative Techniques

Results Point of Contact

• Title: Dr. Felipe Fregni, Director of the Laboratory of Neuromodulation
• Organization: Spaulding Rehabilitation Hospital, Boston, MA.

info@neuromodulationlab.org

617.952.6153

Study Officials

• Felipe Fregni, MD, PhD

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: For the experiment in patients with pelvic pain, the design is parallel. For the experiment in healthy subjects, the design is crossover.

Study Record Dates

• First Submitted: April 20, 2010
• First Posted: June 14, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: May 1, 2013
• Last Updated: April 24, 2020
• Results First Posted: March 15, 2017

Record last verified: 2020-04

Locations

US (1)