FibromyalgiaPhase 1/2NCT00080184
Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia
A Phase 1/2 study testing Low Energy Neurofeedback System in people with Fibromyalgia, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a new form of brainwave biofeedback is effective in the treatment of 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?
- Low Energy Neurofeedback System
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to May 2006
- Phase
- Phase 1/2
- 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
- Diagnosis of fibromyalgia with symptoms for at least 1 year
- Self-report of having attention/concentration, memory, multi-tasking or other thinking difficulties
- Able to read and understand English
- Able to attend treatment sessions weekly and return for planned follow-ups
- Appropriate balance of average delta (<4 Hertz) EEG waveband and alpha (approximately 4-8 Hertz) EEG waveband amplitude on LENS screening (to be determined by study personnel);
Who cannot join
- Other chronic pain condition of major significance
- Current chronic viral infection
- Current other unstable medical condition
- History of spinal, including neck, surgery
- Psychological screening indicates psychotic, suicidal, homicidal, and/or substance abusing
- Use of long-acting opioid medication taken on a continuous 24-hour dosing schedule
- Current involved in litigation regarding pain condition or seeking disability
- History of electroconvulsive therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239-3098
About this study
Official title: Effectiveness of EEG Biofeedback in the Treatment of Fibromyalgia
The purpose of this study is to determine whether a new form of brainwave biofeedback is effective in the treatment of fibromyalgia.
Read the detailed description
Fibromyalgia (FM) is a chronic disorder that involves chronic widespread musculoskeletal pain typically accompanied by fatigue, disordered sleep, cognitive complaints, psychological distress, and impairments in functioning. Treatments to date have been only partially effective and typically of modest benefit. Many persons with FM remain persistently dysfunctional and often disabled. This has given greater impetus for patients to seek complementary and alternative medicine (CAM) therapies. In this study, a variant of electroencephalograph (EEG) biofeedback known as Low Energy Neurofeedback System (LENS) will be used to reduce FM symptoms.
Participants in this study will be randomly assigned to receive either LENS or placebo for several sessions. The Fibromyalgia Impact Questionnaire will be used to assess participants at the end of the study and at the 3- and 6- month follow-up visits.
- Conditions
- Fibromyalgia
- Being tested
- Low Energy Neurofeedback System
- Keywords
- Fibromyalgia, Electroencephalograph (EEG) biofeedback, Electromagnetic stimulation, Neurofeedback, Neurotherapy, Complementary and Alternative Medicine
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Energy Neurofeedback SystemProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2004 (estimated)
- Study startDec 2003
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080184
- Sponsor's protocol ID
- R21AT000930-01A2
- Status last verified
- Aug 2006
- First submitted
- 24 Mar 2004
- Last updated
- 18 Aug 2006
- Results posted
- No
Publications
Mueller HH, Donaldson CC, Nelson DV, Layman M. Treatment of fibromyalgia incorporating EEG-Driven stimulation: a clinical outcomes study. J Clin Psychol. 2001 Jul;57(7):933-52. doi: 10.1002/jclp.1060.
PubMed 11406805
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of EEG Biofeedback in the Treatment of Fibromyalgia
- ClinicalTrials.gov ID
- NCT00080184
- Acronym / sponsor ID
- R21AT000930-01A2
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Electroencephalograph (EEG) biofeedback, Electromagnetic stimulation, Neurofeedback, Neurotherapy, Complementary and Alternative Medicine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Dec 2003
- Study completion
- May 2006
- First posted
- 25 Mar 2004 (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 determine whether a new form of brainwave biofeedback is effective in the treatment of fibromyalgia.
Detailed description
Fibromyalgia (FM) is a chronic disorder that involves chronic widespread musculoskeletal pain typically accompanied by fatigue, disordered sleep, cognitive complaints, psychological distress, and impairments in functioning. Treatments to date have been only partially effective and typically of modest benefit. Many persons with FM remain persistently dysfunctional and often disabled. This has given greater impetus for patients to seek complementary and alternative medicine (CAM) therapies. In this study, a variant of electroencephalograph (EEG) biofeedback known as Low Energy Neurofeedback System (LENS) will be used to reduce FM symptoms.
Participants in this study will be randomly assigned to receive either LENS or placebo for several sessions. The Fibromyalgia Impact Questionnaire will be used to assess participants at the end of the study and at the 3- and 6- month follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of fibromyalgia with symptoms for at least 1 year
- Self-report of having attention/concentration, memory, multi-tasking or other thinking difficulties
- Able to read and understand English
- Able to attend treatment sessions weekly and return for planned follow-ups
- Appropriate balance of average delta (<4 Hertz) EEG waveband and alpha (approximately 4-8 Hertz) EEG waveband amplitude on LENS screening (to be determined by study personnel);
Key exclusion criteria (8 listed)
- Other chronic pain condition of major significance
- Current chronic viral infection
- Current other unstable medical condition
- History of spinal, including neck, surgery
- Psychological screening indicates psychotic, suicidal, homicidal, and/or substance abusing
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 |
|---|---|---|
| Low Energy Neurofeedback System | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 18 Aug 2006.
- Background: PubMed 11406805Mueller HH, Donaldson CC, Nelson DV, Layman M. Treatment of fibromyalgia incorporating EEG-Driven stimulation: a clinical outcomes study. J Clin Psychol. 2001 Jul;57(7):933-52. doi: 10.1002/jclp.1060.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Low Energy Neurofeedback System in people with Fibromyalgia, run by National Center for Complementary and Integrative Health (NCCIH) 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 8 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 18 Aug 2006. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00080184, which also lists 1 linked publication.
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 18 Aug 2006.