Chronic PaintDCSNCT02665988

Adjunctive Transcranial Direct Current Stimulation

A study testing tDCS in people with Chronic Pain and Psychiatric Disorders, run by Baylor College of Medicine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Pain, Psychiatric Disorders
What is being tested?: tDCS
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 4 participants
Where: 1 siteUnited States
Study dates: Jan 2016to Jan 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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%.

Trial locations and contacts

1 site in 1 country.

United States1 site

The Pain Management Program at The Menninger Clinic
Houston, Texas, 77035

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Chronic Pain, Psychiatric Disorders
Being tested: tDCS, Sham tDCS
Keywords: Transcranial Direct Current Stimulation
Medical subject headings: Chronic Pain, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tDCSDevice
Also called transcranial Direct Current Stimulation
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.
Sham tDCSDevice
Also called Sham transcranial Direct Current Stimulation
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.

Study groups in NCT02665988
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Sham tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2016Jan 2018

First posted28 Jan 2016 (estimated)
Study startJan 2016
Primary completionJan 2018
Study completionJan 2018

Why it stopped: We terminated the study because the Pain Management Program closed in January 2018.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic PainStudies of the same condition, open and under way.
More trials run by Baylor College of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02665988
Sponsor's protocol ID: H-36721
Acronym: tDCS
Status last verified: Mar 2021
First submitted: 22 Jan 2016
Last updated: 15 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Description of data may affect potential subject's awareness of sham versus real transcranial Direct Current Stimulation (tDCS)

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02665988
Acronym / sponsor ID: tDCS / H-36721
Conditions: Chronic Pain, Psychiatric Disorders
Keywords: Transcranial Direct Current Stimulation
Study type: Interventional
Recruitment status: TerminatedReason stopped: We terminated the study because the Pain Management Program closed in January 2018.
Enrolment: 4 participants (actual)
Lead sponsor: Baylor College of MedicineUniversity, hospital or other
Study start: Jan 2016
Primary completion: Jan 2018 (actual)
Study completion: Jan 2018 (actual)
First posted: 28 Jan 2016 (estimated)
Results: Posted 15 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Real tDCS	Experimental	Device: tDCSThose 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.
Sham tDCS	Placebo comparator	Device: Sham tDCSThose 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (7 listed)

Presence of actively psychosis, cognitively impairment.
Contraindications to tDCS:
None fluent in the English language.
Presence of known sensitivity to Lidocaine 4%.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
tDCSAlso: transcranial Direct Current StimulationPrior 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.	Device	Real tDCS
Sham tDCSAlso: Sham transcranial Direct Current StimulationParticipants 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.	Device	Sham tDCS

Primary outcome

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.

Results and safety

Results posted to the registry on 15 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Real tDCS	2	2
Sham tDCS	2	2

Primary outcome: 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

Population analysed: Analyses were not performed. Given the premature termination of the clinical program, the limited sample size of participants completing the study, the heterogeneity of chronic pain etiology and psychiatric comorbidity among participants, as well as variable and personalized interventions delivered as a part of the clinical care participants received, the data collected would have been grossly underpowered to provide meaningful results.

Adverse events

Time frame: Participants reported adverse events daily during each day of stimulation (prior to the actual stimulation) as well as weekly for two weeks following the active phase of the trial. Data were collected for 22 days during the following days: days 1-5, days 8-12, day 15, and day 22.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Real tDCS	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Sham tDCS	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Description of data may affect potential subject's awareness of sham versus real transcranial Direct Current Stimulation (tDCS)

Related trials for Chronic Pain

Enrolling by invitation
Efficacy of a Chronic Pain Treatment Prior to Gender-affirming Surgery
Pain Catastrophizing, Pain, Chronic
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Recruiting
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Post-Surgical Pain, Chronic, Post-traumatic Pain, Chronic
Recruiting
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Knee Arthritis, Osteoarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alok Madan, PhD principal investigator

Baylor College of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing tDCS in people with Chronic Pain and Psychiatric Disorders, run by Baylor College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02665988.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.