NCT01754103

Brief Summary

Brain plasticity of cortical activity caused by repetitive tactile stimulation could have a progressive development that was from primary parietal areas, passing over parieto-occipital areas and came secondary to primary occipital areas. This process allows to understand the existence of neurons in the brain and specific areas for certain functions independent of the type of stimulation is performed. By performing repetitive tactile stimulation over a period of 3 months,using a tactile stimulator, our group will try to prove several that repetitive tactile stimulation can create cross-modality and improve recognition and localization of patterns in blind people.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2012

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 21, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 21, 2012

Status Verified

December 1, 2012

Enrollment Period

1.7 years

First QC Date

July 2, 2012

Last Update Submit

December 17, 2012

Conditions

Keywords

blindtactile stimulationcross-modalityvisual qualiaresting state MRIfunctional connectivityneuroplasticity

Outcome Measures

Primary Outcomes (1)

  • MRI Functional Connectivity of the visual pathway

    Functional Connectivity analysis (fcMRI) is a tool that allows functionally associated brain regions to be identified. fcMRI takes advantage of the observation that the brain regions exhibit spontaneous, low frequency variations as measured using blood oxygenation level-dependent (BOLD) imaging.

    1 year

Study Arms (1)

Functional Connectivity MRI

EXPERIMENTAL

Functional Connectivity will be measured by MRI, we will perform one T1WI run as well as three resting state bold based runs. Bold runs parameters: TE 30ms, TR 3000ms, flip angle 90º, gap 0mm, 124 time points, voxel size 3mm, duration 6min18s each, FOV 240x240x141.

Other: Tactile Training

Interventions

Tactile Training to induce neuroplasticity in the visual pathway, measured with functional connectivity MRI

Functional Connectivity MRI

Eligibility Criteria

Age7 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical Diagnosis: Different Causes of blindness were diverse: congenital nystagmus, glaucoma, retinopathy, congenital cataracts, lenticular fibroplasia, macular degeneration, optic atrophy, Peter's anomaly with microphthalmia, retinal detachment, retina necrosis, retinitis pigmentosa and uveitis

You may not qualify if:

  • No history of neurological, psychiatric, cognitive or sensorimotor deficits other than blindness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Complutense de Madrid

Madrid, Madrid, 28040, Spain

RECRUITING

Related Publications (22)

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    PMID: 19643183BACKGROUND
  • Elbert T, Sterr A, Rockstroh B, Pantev C, Muller MM, Taub E. Expansion of the tonotopic area in the auditory cortex of the blind. J Neurosci. 2002 Nov 15;22(22):9941-4. doi: 10.1523/JNEUROSCI.22-22-09941.2002.

    PMID: 12427851BACKGROUND
  • Fortin M, Voss P, Lord C, Lassonde M, Pruessner J, Saint-Amour D, Rainville C, Lepore F. Wayfinding in the blind: larger hippocampal volume and supranormal spatial navigation. Brain. 2008 Nov;131(Pt 11):2995-3005. doi: 10.1093/brain/awn250. Epub 2008 Oct 14.

    PMID: 18854327BACKGROUND
  • Sadato N, Pascual-Leone A, Grafman J, Ibanez V, Deiber MP, Dold G, Hallett M. Activation of the primary visual cortex by Braille reading in blind subjects. Nature. 1996 Apr 11;380(6574):526-8. doi: 10.1038/380526a0.

    PMID: 8606771BACKGROUND
  • Sadato N, Pascual-Leone A, Grafman J, Deiber MP, Ibanez V, Hallett M. Neural networks for Braille reading by the blind. Brain. 1998 Jul;121 ( Pt 7):1213-29. doi: 10.1093/brain/121.7.1213.

    PMID: 9679774BACKGROUND
  • Merabet LB, Hamilton R, Schlaug G, Swisher JD, Kiriakopoulos ET, Pitskel NB, Kauffman T, Pascual-Leone A. Rapid and reversible recruitment of early visual cortex for touch. PLoS One. 2008 Aug 27;3(8):e3046. doi: 10.1371/journal.pone.0003046.

    PMID: 18728773BACKGROUND
  • Burton H, Sinclair RJ, McLaren DG. Cortical activity to vibrotactile stimulation: an fMRI study in blind and sighted individuals. Hum Brain Mapp. 2004 Dec;23(4):210-28. doi: 10.1002/hbm.20064.

    PMID: 15449356BACKGROUND
  • Wheat HE, Goodwin AW, Browning AS. Tactile resolution: peripheral neural mechanisms underlying the human capacity to determine positions of objects contacting the fingerpad. J Neurosci. 1995 Aug;15(8):5582-95. doi: 10.1523/JNEUROSCI.15-08-05582.1995.

    PMID: 7643203BACKGROUND
  • Amedi A, Stern WM, Camprodon JA, Bermpohl F, Merabet L, Rotman S, Hemond C, Meijer P, Pascual-Leone A. Shape conveyed by visual-to-auditory sensory substitution activates the lateral occipital complex. Nat Neurosci. 2007 Jun;10(6):687-9. doi: 10.1038/nn1912. Epub 2007 May 21.

    PMID: 17515898BACKGROUND
  • Swisher JD, Halko MA, Merabet LB, McMains SA, Somers DC. Visual topography of human intraparietal sulcus. J Neurosci. 2007 May 16;27(20):5326-37. doi: 10.1523/JNEUROSCI.0991-07.2007.

    PMID: 17507555BACKGROUND
  • Harris JA, Miniussi C, Harris IM, Diamond ME. Transient storage of a tactile memory trace in primary somatosensory cortex. J Neurosci. 2002 Oct 1;22(19):8720-5. doi: 10.1523/JNEUROSCI.22-19-08720.2002.

    PMID: 12351747BACKGROUND
  • De Volder AG, Catalan-Ahumada M, Robert A, Bol A, Labar D, Coppens A, Michel C, Veraart C. Changes in occipital cortex activity in early blind humans using a sensory substitution device. Brain Res. 1999 Apr 24;826(1):128-34. doi: 10.1016/s0006-8993(99)01275-5.

    PMID: 10216204BACKGROUND
  • Gizewski ER, Gasser T, de Greiff A, Boehm A, Forsting M. Cross-modal plasticity for sensory and motor activation patterns in blind subjects. Neuroimage. 2003 Jul;19(3):968-75. doi: 10.1016/s1053-8119(03)00114-9.

    PMID: 12880825BACKGROUND
  • Zarei M, Johansen-Berg H, Smith S, Ciccarelli O, Thompson AJ, Matthews PM. Functional anatomy of interhemispheric cortical connections in the human brain. J Anat. 2006 Sep;209(3):311-20. doi: 10.1111/j.1469-7580.2006.00615.x.

    PMID: 16928200BACKGROUND
  • Hofer S, Frahm J. Topography of the human corpus callosum revisited--comprehensive fiber tractography using diffusion tensor magnetic resonance imaging. Neuroimage. 2006 Sep;32(3):989-94. doi: 10.1016/j.neuroimage.2006.05.044. Epub 2006 Jul 18.

    PMID: 16854598BACKGROUND
  • Mahncke HW, Connor BB, Appelman J, Ahsanuddin ON, Hardy JL, Wood RA, Joyce NM, Boniske T, Atkins SM, Merzenich MM. Memory enhancement in healthy older adults using a brain plasticity-based training program: a randomized, controlled study. Proc Natl Acad Sci U S A. 2006 Aug 15;103(33):12523-8. doi: 10.1073/pnas.0605194103. Epub 2006 Aug 3.

    PMID: 16888038BACKGROUND
  • Karni A, Meyer G, Jezzard P, Adams MM, Turner R, Ungerleider LG. Functional MRI evidence for adult motor cortex plasticity during motor skill learning. Nature. 1995 Sep 14;377(6545):155-8. doi: 10.1038/377155a0.

    PMID: 7675082BACKGROUND
  • Gougoux F, Zatorre RJ, Lassonde M, Voss P, Lepore F. A functional neuroimaging study of sound localization: visual cortex activity predicts performance in early-blind individuals. PLoS Biol. 2005 Feb;3(2):e27. doi: 10.1371/journal.pbio.0030027. Epub 2005 Jan 25.

    PMID: 15678166BACKGROUND

MeSH Terms

Conditions

Blindness

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tomás Ortiz Alonso, MD PhD

    Universidad Complutense de Madrid

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomas Ortiz Alonso, MD, PhD

CONTACT

Laura Ortiz Teran, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

July 2, 2012

First Posted

December 21, 2012

Study Start

January 1, 2012

Primary Completion

September 1, 2013

Study Completion

December 1, 2014

Last Updated

December 21, 2012

Record last verified: 2012-12

Locations