Chronic PainNCT01402960
Exploration of Parameters of Transcranial Direct Current Stimulation (tDCS) in Chronic Pain
A study testing High Definition Transcranial Direct Current Stimulation (HD-tDCS) in people with Chronic Pain, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
The purpose of this study is to assess the effects of high-definition transcranial direct current stimulation (HD-tDCS) on subjects with chronic musculoskeletal pain. The investigators hypothesize that subjects will show a decrease in pain symptoms in the active anodal stimulation group when compared to sham… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- High Definition Transcranial Direct Current Stimulation (HD-tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to 13 Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Providing informed consent to participate in the study
- 18 to 64 years old
- Having chronic musculoskeletal pain (existing pain for more than 6 months with an average of at least 3 on a 0-10 VAS scale)
- Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine.
- Must have the ability to feel pain as self reported
Who cannot join
- Pregnancy
- Contraindications to tDCS
- metal in the head
- implanted brain medical devices
- History of alcohol or drug abuse within the past 6 months as self reported
- Use of carbamazepine within the past 6 months as self reported.
Show all 11Show fewer
- Severe depression (with a score of >30 in the Beck Depression Inventory)
- History of neurological disorders as self reported.
- History of unexplained fainting spells as self reported,
- History of head injury resulting in more than a momentary loss of consciousness as self reported
- History of neurosurgery as self reported
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02114
About this study
Official title: Exploration of Parameters of tDCS in Chronic Pain Patients
The purpose of this study is to assess the effects of high-definition transcranial direct current stimulation (HD-tDCS) on subjects with chronic musculoskeletal pain. The investigators hypothesize that subjects will show a decrease in pain symptoms in the active anodal stimulation group when compared to sham stimulation.
- Conditions
- Chronic Pain
- Being tested
- High Definition Transcranial Direct Current Stimulation (HD-tDCS)
- Keywords
- High-Definition Transcranial Direct Current Stimulation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Definition Transcranial Direct Current Stimulation (HD-tDCS)Device
Subject will receive active anodal/cathodal and sham HD-tDCS in a randomized, counterbalanced order. Each stimulation session will be separated by at least one week to avoid carryover effects. For both active and sham HD-tDCS the electrodes will be placed over the primary motor cortex, at an intensity of 2mA.
- For active anodal stimulation, the anode will be over the primary motor cortex, and the cathodal electrodes (4) will surround the anode in a 3 inch square, duration will be 20 minutes.
- For active cathodal stimulation, the cathode will be over the primary motor cortex, and the anodal electrodes (4) will surround the cathode in a 3 inch square, duration will be 20 minutes.
- For sham stimulation, the same procedure will be used, however, current will only be active for 30 seconds (current ramping up, then ramping down)
| Study group | Role | What they receive |
|---|---|---|
| Active Anodal HD-tDCS | Experimental | Subject will receive one 20-minute session of active anodal HD-tDCS. Receives: Device: High Definition Transcranial Direct Current Stimulation (HD-tDCS) |
| Active Cathodal HD-tDCS | Experimental | Subject will receive one 20-minute session of active cathodal HD-tDCS. Receives: Device: High Definition Transcranial Direct Current Stimulation (HD-tDCS) |
| Sham HD-tDCS | Sham comparator | Subject will receive one sham session of HD-tDCS Receives: Device: High Definition Transcranial Direct Current Stimulation (HD-tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain scales
Determine whether anodal or cathodal hd-tDCS is effective in reducing pain in subjects with chronic musculoskeletal pain as measured by changes in the Visual Analogue Scale (VAS) for pain. The VAS scale will be measured immediately before the hd-tDCS stimulation sessions and after the hd-tDCS stimulation sessions for each subject for the duration of their participation in the trial. This outcome will also be measured at their baseline visit, and follow-up visit.
Measured: Measured for approximately 5 weeks
Secondary outcomes (1)
Change in cutaneous hyperalgesia/allodynia
To investigate whether treatment with active anodal hd-tDCS alters the phenomenon of central sensitization as indexed by cutaneous allodynia and hyperalgesia by measuring whether anodal tDCS changes the threshold for pain and perception as compared with sham and cathodal hd-tDCS. The subject's pain threshold will be measured immediately before the hd-tDCS stimulation sessions and after the hd-tDCS stimulation sessions for the duration of their participation in the trial. This outcome will also be measured at their baseline visit, and follow-up visit.
Measured: Measured for approximately 5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startApr 2011
- Primary completionFeb 2012
- Study completion13 Feb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Fregni, Spaulding Rehabilitation Hospital
- Investigators
- Felipe Fregni, MD, PhD, MPH, Principal investigator, Spaulding Rehabilitation Hospital (SRH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402960
- Sponsor's protocol ID
- 2010-p-000990
- Status last verified
- Apr 2020
- First submitted
- 29 Jun 2011
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Parameters of tDCS in Chronic Pain Patients
- ClinicalTrials.gov ID
- NCT01402960
- Acronym / sponsor ID
- 2010-p-000990
- Conditions
- Chronic Pain
- Keywords
- High-Definition Transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- 13 Feb 2013 (actual)
- First posted
- 26 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effects of high-definition transcranial direct current stimulation (HD-tDCS) on subjects with chronic musculoskeletal pain. The investigators hypothesize that subjects will show a decrease in pain symptoms in the active anodal stimulation group when compared to sham stimulation.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Anodal HD-tDCS | Experimental | Device: High Definition Transcranial Direct Current Stimulation (HD-tDCS)Subject will receive one 20-minute session of active anodal HD-tDCS. |
| Active Cathodal HD-tDCS | Experimental | Device: High Definition Transcranial Direct Current Stimulation (HD-tDCS)Subject will receive one 20-minute session of active cathodal HD-tDCS. |
| Sham HD-tDCS | Sham comparator | Device: High Definition Transcranial Direct Current Stimulation (HD-tDCS)Subject will receive one sham session of HD-tDCS |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Providing informed consent to participate in the study
- 18 to 64 years old
- Having chronic musculoskeletal pain (existing pain for more than 6 months with an average of at least 3 on a 0-10 VAS scale)
- Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine.
- Must have the ability to feel pain as self reported
Key exclusion criteria (11 listed)
- Pregnancy
- Contraindications to tDCS
- History of alcohol or drug abuse within the past 6 months as self reported
- Use of carbamazepine within the past 6 months as self reported.
- Severe depression (with a score of >30 in the Beck Depression Inventory)
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 |
|---|---|---|
| High Definition Transcranial Direct Current Stimulation (HD-tDCS)Subject will receive active anodal/cathodal and sham HD-tDCS in a randomized, counterbalanced order. Each stimulation session will be separated by at least one week to avoid carryover effects. For both active and sham HD-tDCS the electrodes will be placed over the primary motor cortex, at an intensity of 2mA. * For active anodal stimulation, the anode will be over the primary motor cortex, and the cathodal electrodes (4) will surround the anode in a 3 inch square, duration will be 20 minutes. * For active cathodal stimulation, the cathode will be over the primary motor cortex, and the anodal electrodes (4) will surround the cathode in a 3 inch square, duration will be 20 minutes. * For sham stimulation, the same procedure will be used, however, current will only be active for 30 seconds (current ramping up, then ramping down) | Device | Active Anodal HD-tDCS, Active Cathodal HD-tDCS, Sham HD-tDCS |
Primary outcome
Change in pain scales
Time frame: Measured for approximately 5 weeks
Determine whether anodal or cathodal hd-tDCS is effective in reducing pain in subjects with chronic musculoskeletal pain as measured by changes in the Visual Analogue Scale (VAS) for pain. The VAS scale will be measured immediately before the hd-tDCS stimulation sessions and after the hd-tDCS stimulation sessions for each subject for the duration of their participation in the trial. This outcome will also be measured at their baseline visit, and follow-up visit.
1 secondary outcome
Change in cutaneous hyperalgesia/allodynia
Time frame: Measured for approximately 5 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
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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.
Felipe Fregni, MD, PhD, MPH principal investigator
Spaulding Rehabilitation Hospital (SRH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Definition Transcranial Direct Current Stimulation (HD-tDCS) in people with Chronic Pain, run by Spaulding Rehabilitation Hospital 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 24 Apr 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in pain scales (time frame: Measured for approximately 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2020.