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Adjunctive Transcranial Direct Current Stimulation (tDCS)

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ClinicalTrials.gov Identifier: NCT02665988
Recruitment Status : Terminated (We terminated the study because the Pain Management Program closed in January 2018.)
First Posted : January 28, 2016
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Alok Madan, Baylor College of Medicine

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.


Condition or disease Intervention/treatment Phase
Chronic Pain Psychiatric Disorders Device: tDCS Device: Sham tDCS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : January 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Real tDCS
Those receiving experimental treatment will receive real tDCS during 20-minute periods over the course of 10 sessions. The treatment will be delivered by trained clinical personnel.
Device: tDCS
Prior to initiating the real tDCS trial and to reduce the likelihood of irritation associated with electrical stimulation, a low dose (1/8 of an inch) topical lidocaine (4%) cream will be applied to the skin where the tDCS the sponge-coated, surface electrodes soaked in saline solution will be placed. Neurotargeting tDCS-explorer software, Version 2.3 will be used to locate the left and right DLPFC, where anodal stimulation of the left DLPFC and cathodal stimulation of the right DLPFC will be received. Real tDCS will be applied during 20-minute periods over the course of 10 sessions. After each session, vitamin-E will be applied to the skin where the electrodes had been placed to reduce likelihood of skin irritation.
Other Name: transcranial Direct Current Stimulation

Placebo Comparator: Sham tDCS
Those receiving sham tDCS will receive active tDCS during 20-minute periods over the course of 10 sessions. The treatment will be delivered by trained clinical personnel.
Device: Sham tDCS
Participants randomized to sham tDCS will undergo the same procedures as those in the real tDCS sample, including the same pre-treatment lidocaine 4% cream, localization of electrode placement, actual placement of electrodes, turning on the tDCS device in sham setting but will not receive actual stimulation during the 20 minutes of each session, as well as post-treatment vitamin E.
Other Name: Sham transcranial Direct Current Stimulation




Primary Outcome Measures :
  1. Change from baseline in Visual Analogue Scale (VAS) for pain Change from baseline [ Time Frame: 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 ]
    Visual analogue scale measure for pain. Score range from 0-10. For rating overall pain, ranging from none, mild, moderate, or severe pain.

  2. Change from baseline in Pain Rating Index (PRI) [ Time Frame: 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 ]
    Pain Rating Index through descriptions of pain. Scores can range from 0 to 45 on the PRI, ranging from mild, moderate to severe pain.

  3. Change from baseline in frequency of locations with pain: [ Time Frame: 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 ]
    Participants mark on a figure of the human body each location where pain is experienced, ranging from no location with pain to 5 locations with pain.

  4. Change from baseline in physical activity level [ Time Frame: 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 ]
    Participants will rate on a 0-10 point Likert-scale from light to heavy changes in physical activity level.

  5. Change from baseline in sleep [ Time Frame: 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 ]
    Measures sleep quality by rating 0-10 point likert-scale.


Secondary Outcome Measures :
  1. Performance-based pain tolerance task [ Time Frame: On a weekly basis: day 1, day 8, day 15, and day 22 ]
    The cold pressor test is a measurement of induced pain by placing participants' non-dominant hand in cold water, a stimulus that yields slow and progressively escalating pain of mild to moderate intensity with the participant in complete control of when to withdrawal the limb from the cold water.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02665988


Locations
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United States, Texas
The Pain Management Program at The Menninger Clinic
Houston, Texas, United States, 77035
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Alok Madan, PhD Baylor College of Medicine
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Responsible Party: Alok Madan, Director, Pain Management Program at The Menninger Clinic, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02665988    
Other Study ID Numbers: H-36721
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Description of data may affect potential subject's awareness of sham versus real transcranial Direct Current Stimulation (tDCS)
Keywords provided by Alok Madan, Baylor College of Medicine:
Transcranial Direct Current Stimulation
Additional relevant MeSH terms:
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Chronic Pain
Mental Disorders
Problem Behavior
Pain
Neurologic Manifestations
Signs and Symptoms
Behavioral Symptoms