Transcranial Direct Current Stimulation (tDCS) as Treatment Method for Pain in Fibromyalgia

NCT ID: NCT01598181

Last Updated: 2017-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-10-31

Brief Summary

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The purpose of this study is to investigate Transcranial Direct Current Stimulation as treatment method for pain in fibromyalgia.

Detailed Description

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Fibromyalgia (FIM) is a chronic pain condition with high prevalence. Studies involving neuroimaging techniques have identified functional differences in cerebral pain processing in patients with FIM, as compared to healthy controls. This may support that FIM do have a functional CNS component.

Transcranial Direct Current Stimulation (tDCS) is a non-invasive and safe method for inducing changes in cortical excitability. Previous studies showed that anodal stimulation of M1 may change pain perception, possibly by modulating functional anomalies in the FIM brain. The present study has two main goals:

1. To investigate if tDCS may provide FIM patients with symptom relief due to reduction of pain.
2. To investigate tDCS induced functional changes in the brain by using fMRI.

Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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active tDCS

Group Type EXPERIMENTAL

tDCS NeuroConn DC-stimulator plus

Intervention Type DEVICE

Anodal tDCS, M1, cathode supraorbital left, 2 mA, 20 min, 5 consecutive days.

sham tDCS

tDCS fades out after 20 sec. administered double blind by coded program.

Group Type SHAM_COMPARATOR

tDCS NeuroConn DC-stimulator plus

Intervention Type DEVICE

Anodal tDCS, M1, cathode supraorbital left, 2 mA, 20 min, 5 consecutive days.

sham tDCS

Intervention Type DEVICE

similar montage and time as active. Stimulation fades out after 20 sec.

Interventions

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tDCS NeuroConn DC-stimulator plus

Anodal tDCS, M1, cathode supraorbital left, 2 mA, 20 min, 5 consecutive days.

Intervention Type DEVICE

sham tDCS

similar montage and time as active. Stimulation fades out after 20 sec.

Intervention Type DEVICE

Other Intervention Names

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model 0021 serial-no 0337

Eligibility Criteria

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Inclusion Criteria

* Fibromyalgia (ACR-90 criteria, M79.7 ICD10)
* Mean VAS \> 4 daily 2 weeks prior to study).

Exclusion Criteria

* Severe mental disease
* CNS disease
* Mental retardation
* Age \< 18
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stiftelsen Helse og Rehabilitering

OTHER

Sponsor Role collaborator

University Hospital of North Norway

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Per Aslaksen, ph.d

Role: STUDY_CHAIR

University of Tromso

Locations

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University Hospital of North Norway

Tromsø, Tromsoe, Norway

Site Status

Countries

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Norway

Other Identifiers

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UNorthNorway

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2010/2256/REK n

Identifier Type: -

Identifier Source: org_study_id

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