FibromyalgiaNCT01598181
Transcranial Direct Current Stimulation (tDCS) as Treatment Method for Pain in Fibromyalgia
A study testing tDCS NeuroConn DC-stimulator plus in people with Fibromyalgia, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
The purpose of this study is to investigate Transcranial Direct Current Stimulation as treatment method for pain in fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- tDCS NeuroConn DC-stimulator plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2011to Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fibromyalgia (ACR-90 criteria, M79.7 ICD10)
- Mean VAS > 4 daily 2 weeks prior to study).
Who cannot join
- Severe mental disease
- CNS disease
- Mental retardation
- Age < 18
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate Transcranial Direct Current Stimulation as treatment method for pain in fibromyalgia.
Read the detailed description
Fibromyalgia (FIM) is a chronic pain condition with high prevalence. Studies involving neuroimaging techniques have identified functional differences in cerebral pain processing in patients with FIM, as compared to healthy controls. This may support that FIM do have a functional CNS component.
Transcranial Direct Current Stimulation (tDCS) is a non-invasive and safe method for inducing changes in cortical excitability. Previous studies showed that anodal stimulation of M1 may change pain perception, possibly by modulating functional anomalies in the FIM brain. The present study has two main goals:
- To investigate if tDCS may provide FIM patients with symptom relief due to reduction of pain.
- To investigate tDCS induced functional changes in the brain by using fMRI.
- Conditions
- Fibromyalgia
- Being tested
- tDCS NeuroConn DC-stimulator plus, sham tDCS
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS NeuroConn DC-stimulator plusDevice
Also called model 0021, serial-no 0337
Anodal tDCS, M1, cathode supraorbital left, 2 mA, 20 min, 5 consecutive days.
sham tDCSDevice
similar montage and time as active. Stimulation fades out after 20 sec.
| Study group | Role | What they receive |
|---|---|---|
| active tDCS | Experimental | Not described Receives: Device: tDCS NeuroConn DC-stimulator plus |
| sham tDCS | Sham comparator | tDCS fades out after 20 sec. administered double blind by coded program. Receives: Device: tDCS NeuroConn DC-stimulator plus; Device: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived pain
Pain (intensity and unpleasentness) measured with Visual Analog Scale. Repported at 3 points daily (0900hrs, 1500hrs, 2100hrs) using Short Message System (SMS) 14 days pre-treatment (baseline), during treatment 5 days, and 30 days post-treatment. Measure effect of active\sham tDCS on pain. 2 levels of group (active tDCS\ sham tDCS, 7 repeated measures: pre-treatment day 1, 2 ,3, 4, 5 - post) SMS messages contain 4 questions, mesauring pain intensity / pain unpleasentness (primary outcome), and stress / activation (secondary outcome).
Measured: Change in VAS from baseline up to 49 days.
Secondary outcomes (5)
Cerebral pain processing
Phillps tesla 1.5 fMRi, pathway pain stimulator (Medoc, Israel) fMRI under pain stimulation for 60 participants. 20 recieve active tDCS, 20 recieve sham-tDCS, 20 age and gender matched (matched to active tDCS group) healthy controls. Baseline scan, post treatment scan.
Measured: Change from baseline to post treatment. 7 days.
Rating scales (HADS, SCL90, SF36, FIQ)
Time from inclusion to treatment start determines 30\14 days. Rating scales on Samsung Galaxy tab 10.1. HADS mesure anxiety and depression, SCL 90 measure symtoms of mental illness, SF36 mesure health related life quality, FIQ mesure symptom severity in fibromyalgia.
Measured: Change from baseline to post treatment. 30 days post treatment. Up to 65 days.
Perceived pain, natural history
Pain (intensity and unpleasentness) measured with Visual Analog Scale. 3 times daily (0900hrs, 1500hrs, 2100hrs). A randomly selected sample of participants have VAS measured with SMS for 30 days pre treatment. Intention is to gather natural history sample to compare with a similarly lengthed post-treatment period.
Measured: Baseline compared to post-treatment. Up to 65 days
Perceived stress and activation
Stress and activation measured with Visual Analog Scale. Repported at 3 points daily (0900hrs, 1500hrs, 2100hrs) using Short Message System (SMS) 14 days pre-treatment (baseline), during treatment 5 days, and 30 days post-treatment. Measure effect of active\sham tDCS on stress and activation. 2 levels of group (active tDCS\ sham tDCS, 7 repeated measures: pre-treatment day 1, 2 ,3, 4, 5 - post) Measured using the same instrumet as the primary outcome.
Measured: Change in VAS from baseline to during treatment and after treatment. Up to 49 days.
Perceived stress and activation, natural history
Stress and activation measured with Visual Analog Scale. 3 times daily (0900hrs, 1500hrs, 2100hrs). A randomly selected sample of participants have VAS measured with SMS for 30 days pre treatment. Intention is to gather natural history sample to compare with a similarly lengthed post-treatment period.
Measured: Baseline compared to post-treatment. Up to 65 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startDec 2011
- Primary completionJun 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Stiftelsen Helse og Rehabilitering
- Responsible party
- Sponsor
- Investigators
- Per Aslaksen, ph.d, Study chair, University of Tromso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598181
- Sponsor's protocol ID
- 2010/2256/REK n
- Other IDs
- UNorthNorway
- Status last verified
- Jun 2016
- First submitted
- 15 Mar 2012
- Last updated
- 16 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) as Treatment Method for Pain in Fibromyalgia
- ClinicalTrials.gov ID
- NCT01598181
- Acronym / sponsor ID
- 2010/2256/REK n
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Stiftelsen Helse og Rehabilitering
- Study start
- Dec 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 15 May 2012 (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 investigate Transcranial Direct Current Stimulation as treatment method for pain in fibromyalgia.
Detailed description
Fibromyalgia (FIM) is a chronic pain condition with high prevalence. Studies involving neuroimaging techniques have identified functional differences in cerebral pain processing in patients with FIM, as compared to healthy controls. This may support that FIM do have a functional CNS component.
Transcranial Direct Current Stimulation (tDCS) is a non-invasive and safe method for inducing changes in cortical excitability. Previous studies showed that anodal stimulation of M1 may change pain perception, possibly by modulating functional anomalies in the FIM brain. The present study has two main goals:
- To investigate if tDCS may provide FIM patients with symptom relief due to reduction of pain.
- To investigate tDCS induced functional changes in the brain by using fMRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active tDCS | Experimental | Device: tDCS NeuroConn DC-stimulator plus |
| sham tDCS | Sham comparator | Device: tDCS NeuroConn DC-stimulator plus, Device: sham tDCStDCS fades out after 20 sec. administered double blind by coded program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fibromyalgia (ACR-90 criteria, M79.7 ICD10)
- Mean VAS > 4 daily 2 weeks prior to study).
Key exclusion criteria (4 listed)
- Severe mental disease
- CNS disease
- Mental retardation
- Age < 18
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 |
|---|---|---|
| tDCS NeuroConn DC-stimulator plusAlso: model 0021, serial-no 0337Anodal tDCS, M1, cathode supraorbital left, 2 mA, 20 min, 5 consecutive days. | Device | active tDCS, sham tDCS |
| sham tDCSsimilar montage and time as active. Stimulation fades out after 20 sec. | Device | sham tDCS |
Primary outcome
Perceived pain
Time frame: Change in VAS from baseline up to 49 days.
Pain (intensity and unpleasentness) measured with Visual Analog Scale. Repported at 3 points daily (0900hrs, 1500hrs, 2100hrs) using Short Message System (SMS) 14 days pre-treatment (baseline), during treatment 5 days, and 30 days post-treatment. Measure effect of active\sham tDCS on pain. 2 levels of group (active tDCS\ sham tDCS, 7 repeated measures: pre-treatment day 1, 2 ,3, 4, 5 - post) SMS messages contain 4 questions, mesauring pain intensity / pain unpleasentness (primary outcome), and stress / activation (secondary outcome).
5 secondary outcomes
Cerebral pain processing
Time frame: Change from baseline to post treatment. 7 days.
Rating scales (HADS, SCL90, SF36, FIQ)
Time frame: Change from baseline to post treatment. 30 days post treatment. Up to 65 days.
Perceived pain, natural history
Time frame: Baseline compared to post-treatment. Up to 65 days
Perceived stress and activation
Time frame: Change in VAS from baseline to during treatment and after treatment. Up to 49 days.
Perceived stress and activation, natural history
Time frame: Baseline compared to post-treatment. Up to 65 days
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 16 Feb 2017.
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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.
Per Aslaksen, ph.d study chair
University of Tromso
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 NeuroConn DC-stimulator plus in people with Fibromyalgia, run by University Hospital of North Norway at 1 site in Norway.
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 2 inclusion and 4 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 16 Feb 2017. 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 Norway. 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?
Perceived pain (time frame: Change in VAS from baseline up to 49 days.). 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 16 Feb 2017.