Guided Imagery and Transcranial Direct Current Stimulation (tDCS) in Women With Chronic Pelvic Pain

Chronic pelvic pain (CPP) is a common and often debilitating problem among women. It occurs
below the umbilicus and is severe enough to cause functional impairment or require treatment.
One of the challenges of treating women with CPP is that a single cause is often lacking. CPP
presents as a syndrome of symptoms involving gynecologic, gastrointestinal, urologic, and
musculoskeletal symptoms as well as psychosocial conditions such as depression that
negatively impact quality of life.

The study will consist of one screening visit that may be divided into two visits if needed
to accommodate subject's schedules. The screening visit(s) should take place within four
weeks prior to starting the intervention schedule. The following will be completed at the
screening visit(s): pelvic/levator exam, body mass index (BMI), last menstrual period,
medication use, electroencephalogram (EEG), questionnaires (CAGE-AID Questionnaire, Beck
Depression Inventory, Interstitial Cystitis Symptom/Problem Index, Generalized Anxiety
Disorder 7 item scale, McGill Pain Questionnaire, Pain Catastrophizing Scale, Visual Analog
Scale for pain). The subject will complete 16 intervention visits over 12 weeks.

The study intervention visits will be conducted on the Beaumont Hospital- Royal Oak campus by
licensed nurses and/or physicians. The initial 10 sessions will occur Monday through Friday,
within a 21-day period (allowing for missed days due to unexpected emergencies and/or
inclement weather). Excluding weekends, there should be no more than 2 days between the
intervention sessions. Each intervention is 20 minutes in duration. After completing the
initial 10 sessions, subjects will complete an additional 6 weekly maintenance sessions
according to treatment group.

Objectives:

1. To assess the change in EEG alpha brain waves in women with CPP after guided imagery
sessions with tDCS actual or sham treatments.

2. To assess the change in pain, urinary symptoms, and quality of life in women after
guided imagery sessions with tDCS actual or sham sessions.

Endpoints:

Primary objective/endpoint: Change in alpha wave frequency on EEG after 10 sessions of tDCS
and guided imagery, versus 10 sessions of sham tDCS and guided imagery compared to baseline.

Secondary objective/endpoint:

Change in pain levels (0-10) on a Visual Analog Scale (VAS) after 10 intervention sessions
and at end of study compared to baseline.

Hypothesis:

The combination of tDCS and Guided Imagery (GI) will enhance patient outcomes, as evidenced
by differences in alpha brain wave changes, pain and quality of life (QOL) measures between
tDCS actual and sham treatment groups.

Inclusion Criteria:

- 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

- Self-reported pelvic pain score ≥ 4 on VAS

- Levator muscle tenderness of 4 or greater in at least one region of the pelvic floor
on transvaginal palpation

- Subject agrees to not start any new treatment (medication or otherwise) throughout the
study treatment and follow up periods.

- Subject agrees to maintain stable doses of all current medications throughout the
study treatment and follow-up period.

Exclusion Criteria:

- Pacemaker

- History of seizures during the last 2 years or diagnosis of epilepsy

- Currently using tobacco

- A score of ≥ 2 on the CAGE-AID alcohol and substance abuse screening questionnaire Use
of carbamazepine, oxcarbazepine, phenytoin, pramipexole or cabergoline within the past
6 months as self-reported

- Severe depression with a Beck's depression inventory (BDI) score > 30.

- Parkinson's Disease

- Any condition, including neurological or psychiatric illness, which per investigators'
judgement may increase subject risk

- History of Hunner's lesion in the medical record

- Lactation, pregnancy, or refusal to use medically approved/reliable birth control in
women of child-bearing potential

- Sacral, 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