Adjunctive Transcranial Direct Current Stimulation



Status:Recruiting
Conditions:Chronic Pain, Chronic Pain, Psychiatric
Therapuetic Areas:Musculoskeletal, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:5/4/2016
Start Date:January 2016
End Date:December 2018
Contact:Alok Madan, PhD
Email:amadan@menninger.edu
Phone:713-275-5085

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A Single-Blind, Randomized Control Trial of Adjunctive Transcranial Direct Current Stimulation (tDCS) for Chronic Pain Among Patients Receiving Specialized, Inpatient Multi-Modal Pain Management

Transcranial direct current stimulation (tDCS) is an investigational device that has not
been approved for the treatment of any medical condition by the FDA but is allowed to be
used for research purposes. In clinical trials tDCS has been associated with pain relief by
decreasing the intensity and duration of chronic pain. tDCS potentially works by stimulating
the brain by delivering an extremely low-level electrical current to areas below the
forehead - areas associated with chronic pain. It is anticipated that this current will
increase brain activity or the likelihood of brain activity in these areas, affecting
individual's ability to regulate pain.

The purpose of this study is to compare eligible participants in the Pain Management Program
at The Menninger Clinic receiving adjunctive real transcranial Direct Current Stimulation
(tDCS) versus those receiving sham tDCS in the resolution of chronic pain. The primary
objectives are: (1) improving pain tolerance and (2) improving subjective pain experience.
Secondary objectives are: (1) improving subjective experience of sleep quality and (2)
increasing physical activity.

Chronic or persistent pain is pain that continues when it should not be present; it is
ongoing or recurrent pain, lasting beyond the usual course of acute illness or injury, and
which unfavorably affects the individual's well-being. The Institute of Medicine (2011)
estimates that 116 million American adults experience chronic pain with direct and indirect
costs to the US economy totaling in excess of half a trillion dollars annually. Current
treatments for chronic pain are only partially effective, especially when used alone. There
is a critical need to develop new and more effective treatments for chronic pain.
Transcranial Direct Current Stimulation (tDCS) may be helpful as an additional treatment for
patients with chronic pain.

Doctors and scientists conducting this research study want to evaluate the effectiveness of
an investigational device (tDCS) that delivers a form of brain stimulation as an additional
treatment to standard of care in the Menninger Clinic's Pain Management Program. Stimulation
with tDCS as an adjunctive to medication-based treatments as well non-medication treatments
options (such as physical therapy and psychotherapy) may improve an individual's ability to
tolerate the physical and emotional distress associated with chronic pain. Therefore the
investigators propose to engage in a clinical trial of adjunctive tDCS for chronic pain,
restricting enrollment to the population receiving services in the Pain Management Program.

Inclusion Criteria:

1. Males and females greater than equal to 18 years old.

2. Females with a confirmed negative pregnancy test (which is conducted within 24 hours
of admission to the hospital as part of standard of clinical care).

3. Confirmed diagnosis of chronic pain.

4. Must be admitted to the Pain Management Program at The Menninger Clinic.

Exclusion Criteria:

1. Presence of actively psychosis, cognitively impairment.

2. Contraindications to tDCS:

1. Presence of any preexisting irritation, cuts, or lesions where the tDCS will be
placed (i.e., the forehead).

2. Presence of any preexisting unstable medical conditions, or conditions that may
increase the risk of stimulation such as uncontrolled epilepsy.

3. Presence of history of severe cranial trauma with alteration of the cranial
anatomy or metallic intracranial implants.

3. None fluent in the English language.

4. Presence of known sensitivity to Lidocaine 4%.
We found this trial at
1
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Houston, Texas 77035
Phone: 713-275-5085
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Houston, TX
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