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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00080184 |
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Date of registration:
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24/03/2004 |
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Primary sponsor: |
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Public title:
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Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia
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Scientific title:
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Effectiveness of EEG Biofeedback in the Treatment of Fibromyalgia |
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Date of first enrolment:
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December 2003 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00080184 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion criteria:
- 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);
Exclusion criteria:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Fibromyalgia
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Intervention(s)
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Procedure: Low Energy Neurofeedback System
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Secondary ID(s)
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R21 AT000930-01A2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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