NCT00080184

Brief Summary

The purpose of this study is to determine whether a new form of brainwave biofeedback is effective in the treatment of fibromyalgia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2003

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2004

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

August 18, 2006

Status Verified

August 1, 2006

First QC Date

March 24, 2004

Last Update Submit

August 16, 2006

Conditions

Fibromyalgia

Keywords

FibromyalgiaElectroencephalograph (EEG) biofeedbackElectromagnetic stimulationNeurofeedbackNeurotherapyComplementary and Alternative Medicine

Interventions

Low Energy Neurofeedback SystemPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239-3098, United States

Location

Related Publications (1)

  • 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.

    PMID: 11406805BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

March 24, 2004

First Posted

March 25, 2004

Study Start

December 1, 2003

Study Completion

May 1, 2006

Last Updated

August 18, 2006

Record last verified: 2006-08

Locations

US(1)