Adjunctive Transcranial Direct Current Stimulation

NCT02665988 | Terminated Results

• 1 other identifier: H-36721
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Psychiatric Disorders

Keywords

Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Visual Analogue Scale (VAS) for Pain Change From Baseline

  Visual analogue scale measure for pain. Score range from 0-10. For rating overall pain, ranging from none, mild, moderate, or severe pain.

  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

Study Arms (2)

Real tDCS

EXPERIMENTAL

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

Sham tDCS

PLACEBO COMPARATOR

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

Interventions

tDCS DEVICE

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.

Also known as: transcranial Direct Current Stimulation

Real tDCS

Sham tDCS DEVICE

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.

Also known as: Sham transcranial Direct Current Stimulation

Sham tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females greater than equal to 18 years old.
• 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).
• Confirmed diagnosis of chronic pain.
• Must be admitted to the Pain Management Program at The Menninger Clinic.

You may not qualify if:

• Presence of actively psychosis, cognitively impairment.
• Contraindications to tDCS:
• Presence of any preexisting irritation, cuts, or lesions where the tDCS will be placed (i.e., the forehead).
• Presence of any preexisting unstable medical conditions, or conditions that may increase the risk of stimulation such as uncontrolled epilepsy.
• Presence of history of severe cranial trauma with alteration of the cranial anatomy or metallic intracranial implants.
• None fluent in the English language.
• Presence of known sensitivity to Lidocaine 4%.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

The Pain Management Program at The Menninger Clinic

Houston, Texas, 77035, United States

Location

MeSH Terms

Conditions

Chronic Pain; Mental Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Dr. Alok Madan
• Organization: Houston Methodist Hospital

amadan@houstonmethodist.org

832-930-1662

Study Officials

• Alok Madan, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pain Management Program at The Menninger Clinic

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: January 28, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: April 15, 2021
• Results First Posted: April 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)