Open Label Extension Study of tDCS Plus Guided Imagery for Women With Chronic Pelvic Pain (CPP)

Study Overview
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Brief Summary
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This is an open label extension study trial of tDCS with a standardized guided imagery intervention. Up to 20 women with chronic pelvic pain, who completed participation in the initial randomized trial (IRB 2019-362) will be enrolled. Subjects will complete 5 tDCS treatments with guided imagery and a 1-week follow-up visit.

Detailed Description
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Chronic pelvic pain (CPP) is a common and often debilitating in women. It occurs below the umbilicus and is severe enough to cause functional impairment or require treatment. Transcranial Direct Stimulation (tDCS) is a non-invasive brain stimulation technique. As tDCS modulates nerve activity and connectivity, it is also expected to cause measurable changes in brain activity. Guided imagery is a form of hypnosis using words to direct one's thoughts and attention to imagined sensations. Guided imagery has demonstrated efficacy in reducing pain related to many conditions including cancer pain, chronic lower back pain, and post-operative pain. More information is needed to evaluate the effects of tDCS and guided imagery in the treatment of chronic pelvic pain. This study consists of one screening visit, 5 study intervention visits, and a 1-week follow-up visit. After obtaining informed consent, study staff will assess for changes in medical history an pelvic pain treatments since the end of participation in Part 1 (IRB 2019-362). Urine will be collected for urinalysis and a urine pregnancy test will be collected for women of childbearing potential. If urinalysis and pregnancy test are negative, subjects will complete questionnaires, vitals, and a baseline EEG will be conducted. At the 5 interventional visits, transcranial direct stimulation (tDCS) with guided imagery will be delivered. A EEG will be completed after the 1st and 5th treatment visits. At each visit questionnaires will be administered and urine pregnancy test, if the woman is of childbearing potential. At the 1-week follow- up visit, an EEG will be performed, questionnaires administered.

Official Title
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A Randomized, Single Blind, Exploratory Study of the Acute Effects of Guided Imagery and Transcranial Direct Current Stimulation (tDCS) on Electroencephalogram (EEG) Alpha Brain Waves and Pain Levels in Women With Chronic Pelvic Pain

Conditions
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Chronic Pelvic Pain

Intervention / Treatment
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* Device: Active tDCS with guided imagery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Study participants must have participated and completed: (IRB 2019-362) A Multi-Stage, Randomized, Single Blind, Pilot study of the Acute Effects of Guided Imagery and Transcranial Direct Current Stimulation (tDCS) on EEG Alpha Brain Waves and Pain Levels in Women with Chronic Pelvic Pain, referred to as Part Female Age 18 to 64 years Women must either be unable to become pregnant (are surgically sterile or postmenopausal) or must use an approved method of birth control throughout the study period. Self-reported CPP defined as pelvic pain that is non-cyclical and of at least 6 months duration and refractory to other treatments Subject agrees to not start any new treatment (medication or otherwise) throughout the treatment and follow up periods. Subject agrees to maintain stable doses of all current medications throughout the treatment and follow-up period. Exclusion Criteria: History of seizures during the last 2 years or diagnosis of epilepsy Pacemaker Currently using tobacco Use of carbamazepine, oxcarbazepine, phenytoin, pramipexole or cabergoline within the past 6 months as self-reported Parkinson's Disease Any condition, including neurological or psychiatric illness, which per investigators' judgement may increase subject risk History of Hunner's lesions Lactation, pregnancy, or refusal to use medically approved/reliable birth control in women of child-bearing potential Sacral or pudendal Interstim® or spinal cord stimulator that is on Contraindications to tDCS stimulation (e.g. metal in the head, implanted brain medical devices, scalp wounds or infections, etc) History of head injury resulting in more than a momentary loss of consciousness during the last 2 years Deferral Criteria If a subject has a confirmed UTI per investigator's clinical judgment, she will be deferred until treatment is completed and symptoms resolve Participating in another intervention study, or received an investigational drug or device within 4 weeks prior to screening Subject received bladder hydrodistention within the past 12 weeks Within the past four weeks, initiation of any new medications or any intravesical treatment for treatment of IC/BPS. Within the past 24 weeks received any surgery or procedure which may impact the pelvic floor Note: For the sake of preserving scientific integrity, one of more of the eligibility criteria have been left off this list posting while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is an open label extension exploratory study. All eligible subjects will receive active tDCS with guided imagery.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active tDCS with guided imagery<br>Subjects will receive 2 miliamps of electrical stimulation to the brain (transcranial direct stimulation-tDCS) for 20 minutes concurrently while listening to a guided imagery CD specifically designed for women with chronic pelvic pain. | Device: Active tDCS with guided imagery<br>* The subject will be positioned in the sitting/reclining position in a quiet room with lights dimmed. The tDCS device and audio headphones will be placed on the subject's head. The tDCS device to be used is the Soterix Medical 1X1 device using 2.0 mA of current. The electrodes that will be used will be standard sponge electrodes. The subject will listen to a scripted guided imagery CD specifically developed for women with chronic pelvic pain through the audio headphones. The guided imagery plus active tDCS arm will have 20 minutes of stimulation with 25 minutes of guided imagery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess changes in EEG alpha brain waves in women with CPP after 5 sessions of transcranial direct simulation (tDCS) administered concurrently with guided imagery (GI). | Change in alpha wave frequency on EEG between baseline and after the 5th interventional treatment of tDCS with guided imagery. | At 1-week follow up visit. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess changes in pain in women with CPP after 5 sessions of transcranial direct simulation (tDCS) administered concurrently with guided imagery (GI). | A 10-point VAS for pain will be utilized at screening to determine eligibility, and pre- and post-treatment to measure the short-term effects of each treatment. VAS is scored from 0-10. | At 1-week follow-up. | 
| To assess changes in urinary symptoms in women with CPP after 5 sessions of transcranial direct simulation (tDCS) administered concurrently with guided imagery (GI) as measured by the Overactive Bladder Questionnaire short form (OAB-q SF). | Changes in subject-reported bother related to overactive bladder symptoms as measured by the Overactive Bladder Questionnaire short form (OAB-q SF). The OAB-q SF consists of two scales assessing symptom bother and health-related quality of life (HRQOL) in patients with OAB. Each question is rated on a 6-point scale with 1 = not at all and 6= a very great deal. | At 1-week follow-up visit. | 
| To assess changes in urinary symptoms in women with CPP after 5 sessions of transcranial direct simulation (tDCS) administered concurrently with guided imagery (GI) as measured by the Interstitial Cystitis Symptom Index and Problem Index ICSI-PI). | The IC symptom and problem index measure urinary and pain symptoms and assess how problematic symptoms are for patients with IC/BPS. Scored (0-36). A higher score indicates greater severity of symptoms. | At 1-week follow-up visit. | 
| To assess changes in QOL in women with CPP after 5 sessions of transcranial direct simulation (tDCS) administered concurrently with guided imagery (GI). | The Global Response Assessments (GRA) for Pain and QOL will administered. GRA evaluates the subject's perceptions of overall improvement in symptoms on a 7-point scale (markedly worse, moderately worse, mildly worse, same, slightly improved, moderately improved, or markedly improved). | At 1-week follow-up visit. |