Clinical trial NCT02665988: Adjunctive Transcranial Direct Current Stimulation
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Pain
Psychiatric Disorders
Keywords: Transcranial Direct Current Stimulation
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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%.

Primary outcomes:
measure: Change From Baseline in Visual Analogue Scale (VAS) for Pain Change From Baseline
timeFrame: On a weekly basis: 1) Day 1 (first day of tDCS). 2) Day 8 (after first week with post 5 consecutive sessions of tDCS followed by 2 consecutive days without tDCS). 3) Day 15 (after second week post another 5 sessions of tDCS followed by 2 consecutive days
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The Pain Management Program at The Menninger Clinic
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Alok Madan, PhD
role: PRINCIPAL_INVESTIGATOR
References: