NCT00542906

Brief Summary

The implication of the second somatosensory area (SII) and the insular cortex in the processing of somatosensory inputs is now well established. However the functional anatomy of these areas hidden in the depth of the sylvian scissure remain mostly unknown. The aim of this fMRI study is to determine the functional cartography of SII and insula. The localization of responses to different somatosensory stimuli (slight touch, warm, cold, heat pain and arthrokinesia) applied on the left hand of 25 healthy volunteers, will be compared.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Oct 2007

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

October 1, 2007

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 12, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

June 17, 2009

Status Verified

June 1, 2009

Enrollment Period

6 months

First QC Date

October 11, 2007

Last Update Submit

June 16, 2009

Conditions

Keywords

healthy volunteersSomatosensory stimulifMRIsecond somatosensory areainsular cortexfunctional anatomy

Outcome Measures

Primary Outcomes (1)

  • Comparison of euclidian distances between the centroids of clusters activations for the different types of stimulations into SII and insula.

    one day

Secondary Outcomes (1)

  • Determine the Talairach coordinates of the centroids of clusters of activations for the different types of somatosensory stimuli into SII and insula

    one day

Study Arms (1)

1

OTHER

healthy volunteers

Other: localization

Interventions

localization of the several types of somatosensory stimuli

1

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteers will be included ranging in age from 18 to 50 years
  • contraception needed for women
  • right handed
  • All the subjects have to give their written informed consent.

You may not qualify if:

  • pregnancy
  • neurological or psychiatric disease
  • drugs taken \<12h before fMRI
  • contra-indications to fMRI : pacemaker, clip, metallic device
  • Refusing to be informed of the presence of a cerebral abnormality, detected during MRI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Neurologie - CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

Related Publications (2)

  • Mazzola L, Isnard J, Mauguiere F. Somatosensory and pain responses to stimulation of the second somatosensory area (SII) in humans. A comparison with SI and insular responses. Cereb Cortex. 2006 Jul;16(7):960-8. doi: 10.1093/cercor/bhj038. Epub 2005 Sep 21.

    PMID: 16177270BACKGROUND
  • Peyron R, Schneider F, Faillenot I, Convers P, Barral FG, Garcia-Larrea L, Laurent B. An fMRI study of cortical representation of mechanical allodynia in patients with neuropathic pain. Neurology. 2004 Nov 23;63(10):1838-46. doi: 10.1212/01.wnl.0000144177.61125.85.

    PMID: 15557499BACKGROUND

Study Officials

  • Laure Mazzola, MD

    CHU de Saint-Etienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 11, 2007

First Posted

October 12, 2007

Study Start

October 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

June 17, 2009

Record last verified: 2009-06

Locations