Working Memory Training for Chronic Neuropathic and Fibro... | NCT02824588

Studies
Working Memory Training for Chronic Neuropathic and Fibromyalgia Pain

NCT02824588

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Sep 5, 2018Actual

Enrollment

82Actual

Phase

Not Applicable

Conditions

Working Memory Deficits
Neuropathic Pain
Fibromyalgia

Interventions

Working Memory Training
Internet use

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016Actual

Primary Completion Date

Sep 2, 2018Actual

Completion Date

Sep 2, 2018Actual

First Submitted Date

Jun 27, 2016

First Submission Date that Met QC Criteria

Jul 1, 2016

First Posted Date

Jul 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2018

Last Update Posted Date

Sep 5, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Henrik Børsting Jacobsen, Post Doctoral Fellow, Oslo University HospitalPrincipal Investigator

Lead Sponsor

Oslo University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Working Memory Training	Behavioral: Working Memory Training
Control	Active Comparator	Internet use	Behavioral: Internet use

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Working Memory Training	Behavioral	Training mental flexibility	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective neuropsychological tests	CANTAB test battery	36 weeks

Secondary Outcomes

Measure	Description	Time Frame
Pain intensity	VAS scale	36 weeks
Stress regulation	Hair cortisol	36 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital		Oslo		0450	Norway

Condition Browse Module

MeSH Terms

ID	Term
D009437	Neuralgia
D005356	Fibromyalgia
D010146	Pain

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided