Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 41 of 97 for:    fibromyalgia | Open Studies | Interventional Studies

Working Memory Training for Chronic Neuropathic and Fibromyalgia Pain (NEPA)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2016 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Henrik Børsting Jacobsen, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT02824588
First received: June 27, 2016
Last updated: July 1, 2016
Last verified: July 2016
  Purpose

The goal of this project is to investigate and improve executive control function in two distinct pain conditions, namely neuropathic pain and fibromyalgia (FM). It is hypothesized that there is a significant difference in the executive control function of patients with neuropathic pain and FM pain. It is also hypothesized that all participants with poor executive control functioning will report significant improvements in pain intensity, functioning and cognitive complaints following cognitive training. The study tests and influence the working memory concepts of inhibition, updating and flexibility through an experimental, cross-over treatment design.

To perform the experiment, we will recruit 160 participants (80 with neuropathic pain and 80 with FM) from the Departments of pain management and research at St Olav's University Hospital and Oslo University Hospital (OUS). The proposed design will be able to determine whether or not executive control, processing speed and memory function differs in two distinct populations of pain patients. Moreover, whether impairments are amended by computerized training.


Condition Intervention Phase
Working Memory Deficits
Neuropathic Pain
Fibromyalgia
Behavioral: Relational Frame Training
Behavioral: Internet use
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Executive Control, Processing Speed and Memory Function in Long- Term Peripheral Neuropathic Pain and Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Objective neuropsychological tests [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    CANTAB test battery


Secondary Outcome Measures:
  • Pain intensity [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    VAS scale

  • Stress regulation [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    Hair cortisol

  • Symptoms of depression [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    Hopkins symptom checklist

  • Sleep duration, quality and awakening [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    Actigraphy

  • Quality of life [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    Self-reported quality of life EQ-5D

  • Medication use [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    Registered analgetic usage

  • Self-reported memory and concentration impairments [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    Everyday Memory Questionnaire

  • Self-reported cognitive intrusion [ Time Frame: 36 weeks ]
    Questionnaire


Estimated Enrollment: 160
Study Start Date: September 2016
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Relational Frame Training
Behavioral: Relational Frame Training
Training same/different, hierarchical classes and perspective takin
Active Comparator: Control
Internet use
Behavioral: Internet use
Used as control for time spent on computer

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of fibromyalgia or neuropathic pain
  • Confirmed objective cognitive impairments on the CANTAB battery compared to IQ control

Exclusion Criteria:

  • Mania, suicidal ideation and/or active psychosis
  • No objective cognitive impairments
  • Personality disorders
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02824588

Contacts
Contact: Henrik B Jacobsen, PhD +47 23 02 61 61 henrik.borsting@gmail.com
Contact: Audun Stubhaug, PhD +47 23 02 61 61 audun.stubhaug@medisin.uio.no

Locations
Norway
Oslo University Hospital Recruiting
Oslo, California, Norway, 0450
Contact: Henrik B Jacobsen, PhD    +47 23 02 61 61    henrik.borsting@gmail.com   
Contact: Audun Stubhaug, PhD    +47 23 02 61 61    audun.stubhaug@medisin.uio.no   
Sponsors and Collaborators
Oslo University Hospital
  More Information

Responsible Party: Henrik Børsting Jacobsen, Post Doctoral Fellow, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02824588     History of Changes
Other Study ID Numbers: 2016/8442 
Study First Received: June 27, 2016
Last Updated: July 1, 2016
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Oslo University Hospital:
Pain
Working memory

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Neuralgia
Memory Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Signs and Symptoms
Neurobehavioral Manifestations

ClinicalTrials.gov processed this record on December 02, 2016