Working Memory DeficitsNEPANCT02824588
Working Memory Training for Chronic Neuropathic and Fibromyalgia Pain
A study testing Working Memory Training and Internet use in people with Working Memory Deficits and Neuropathic Pain, run by Oslo University Hospital at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Working Memory Deficits, Neuropathic Pain, Fibromyalgia
- What is being tested?
- Working Memory Training and Internet use
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2016to 2 Sep 2018
- 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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of fibromyalgia or neuropathic pain
- Confirmed objective cognitive impairments on the CANTAB battery compared to IQ control
Who cannot join
- Mania, suicidal ideation and/or active psychosis
- No objective cognitive impairments
- Personality disorders
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Executive Control, Processing Speed and Memory Function in Long- Term Peripheral Neuropathic Pain and Fibromyalgia
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.
- Conditions
- Working Memory Deficits, Neuropathic Pain, Fibromyalgia
- Being tested
- Working Memory Training, Internet use
- Keywords
- Pain, Working memory
- Medical subject headings
- Neuralgia, Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Working Memory TrainingBehavioural
Training mental flexibility
Internet useBehavioural
Used as control for time spent on computer
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Working Memory Training Receives: Behavioral: Working Memory Training |
| Control | Active comparator | Internet use Receives: Behavioral: Internet use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective neuropsychological tests
CANTAB test battery
Measured: 36 weeks
Secondary outcomes (8)
Pain intensity
VAS scale
Measured: 36 weeks
Stress regulation
Hair cortisol
Measured: 36 weeks
Symptoms of depression
Hopkins symptom checklist
Measured: 36 weeks
Sleep duration, quality and awakening
Actigraphy
Measured: 36 weeks
Quality of life
EQ-5D
Measured: 36 weeks
Medication use
Registered analgetic usage
Measured: 36 weeks
Self-reported memory and concentration impairments
Everyday Memory Questionnaire
Measured: 36 weeks
Self-reported cognitive intrusion
Questionnaire
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startSep 2016
- Primary completion2 Sep 2018
- Study completion2 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Working Memory DeficitsStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henrik Børsting Jacobsen, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824588
- Sponsor's protocol ID
- 2016/8442
- Acronym
- NEPA
- Status last verified
- Sep 2018
- First submitted
- 27 Jun 2016
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Executive Control, Processing Speed and Memory Function in Long- Term Peripheral Neuropathic Pain and Fibromyalgia
- ClinicalTrials.gov ID
- NCT02824588
- Acronym / sponsor ID
- NEPA / 2016/8442
- Conditions
- Working Memory Deficits, Neuropathic Pain, Fibromyalgia
- Keywords
- Pain, Working memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 2 Sep 2018 (actual)
- Study completion
- 2 Sep 2018 (actual)
- First posted
- 6 Jul 2016 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Working Memory TrainingWorking Memory Training |
| Control | Active comparator | Behavioral: Internet useInternet use |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed diagnosis of fibromyalgia or neuropathic pain
- Confirmed objective cognitive impairments on the CANTAB battery compared to IQ control
Key exclusion criteria (4 listed)
- Mania, suicidal ideation and/or active psychosis
- No objective cognitive impairments
- Personality disorders
- Pregnancy
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 |
|---|---|---|
| Working Memory TrainingTraining mental flexibility | Behavioural | Intervention |
| Internet useUsed as control for time spent on computer | Behavioural | Control |
Primary outcome
Objective neuropsychological tests
Time frame: 36 weeks
CANTAB test battery
8 secondary outcomes
Pain intensity
Time frame: 36 weeks
Stress regulation
Time frame: 36 weeks
Symptoms of depression
Time frame: 36 weeks
Sleep duration, quality and awakening
Time frame: 36 weeks
Quality of life
Time frame: 36 weeks
Medication use
Time frame: 36 weeks
Self-reported memory and concentration impairments
Time frame: 36 weeks
Self-reported cognitive intrusion
Time frame: 36 weeks
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 5 Sep 2018.
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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 study testing Working Memory Training and Internet use in people with Working Memory Deficits and Neuropathic Pain, run by Oslo University Hospital 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 5 Sep 2018. 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. 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?
Objective neuropsychological tests (time frame: 36 weeks). 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 5 Sep 2018.