Neuroplasticity in Blind Subjects After Repetitive Tactile Stimulation

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Universidad Complutense de Madrid
Sponsor:
Collaborator:
Harvard University
Information provided by (Responsible Party):
Tomas Ortiz Alonso, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier:
NCT01754103
First received: July 2, 2012
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Blindness
Other: Tactile Training

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Neuroplasticity in Blind Subjects After Repetitive Tactile Stimulation

Further study details as provided by Universidad Complutense de Madrid:

Primary Outcome Measures:
  • MRI Functional Connectivity of the visual pathway [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 24
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Functional Connectivity MRI
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
Tactile Training to induce neuroplasticity in the visual pathway, measured with functional connectivity MRI

Detailed Description:

The investigators will use passive repetitive tactile stimulation over a period of 3 months, one hour a day for five days a week, with vertical, horizontal and oblique lines generated randomly by a tactile stimulator. Our aim is (a) to study if repetitive tactile stimulation can create cross-modality and improve recognition and localization of patterns in blind people, (b) to evaluate the impact of this training on brain activity the investigators performed high-density scalp EEG recording during the initial stimulation session and in the last one. And (c) measure the functional connectivity of the brain with resting state MRI pre and post training. The resting state MRI protocol consist on one run of T1WI and three bold runs (TE=30ms,TR=3000ms, flip angle 90º,voxel size 3mm, 124 time points, 0 gap).

Cross-modality sensory stimulation may offer a good opportunity to improve recognition, localization and navigation in blind people. Although the neural substrate of this multimodality integration is not fully understood yet. Some areas of the brain, mainly the lateral occipital cortex, are specialized for visual object recognition and they can be activated by tactile stimuli. This activation of the visual cortex might lead to visual-like perception, regardless of the sensory input modality.

In the blind the high demand required by object recognition appears to recruit also ventral and dorsal occipital areas. Blindness modifies neocortical processing of non-visual tasks, including frontoparietal and visual regions during tactile stimulation. It is also known that people with blindness proficient in the use of a visuo-tactile sensory substitution device that presents visual images as patterns of electric stimuli to the subject's tongue, like Bach-y-Rita and Ptito said, show occipital cortex activation in an orientation-discrimination task.

As far as the investigators know there are no studies aimed at understanding the relationship between activation of lateral occipital cortex and the ability to recognize objects presented to the hand along time. In particular, the investigators tested if repetitive passive tactile stimulation leads to activation of visual areas and recognition of spatial patterns in people with blindness.

  Eligibility

Ages Eligible for Study:   7 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • No history of neurological, psychiatric, cognitive or sensorimotor deficits other than blindness.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754103

Contacts
Contact: Tomas Ortiz Alonso, MD, PhD +34 91 394 1495 tortiz@med.ucm.es
Contact: Laura Ortiz Teran, MD, PhD teran@nmr.mgh.harvard.edu

Locations
Spain
Universidad Complutense de Madrid Recruiting
Madrid, Spain, 28040
Contact: Tomas Ortiz Alonso, MD ,PhD    +34 91 394 1495 ext 1495    tortiz@med.ucm.es   
Contact: Laura Ortiz Teran, MD, PhD    +1 617 945 3384    teran@nmr.mgh.harvard.edu   
Principal Investigator: Tomas Ortiz Alonso, MD, PhD         
Sponsors and Collaborators
Universidad Complutense de Madrid
Harvard University
Investigators
Principal Investigator: Tomás Ortiz Alonso, MD PhD Universidad Complutense de Madrid
  More Information

Publications:

Responsible Party: Tomas Ortiz Alonso, MD PhD, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT01754103     History of Changes
Other Study ID Numbers: VISION TACTIL
Study First Received: July 2, 2012
Last Updated: December 17, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Universidad Complutense de Madrid:
blind
tactile stimulation
cross-modality
visual qualia
resting state MRI
functional connectivity
neuroplasticity

ClinicalTrials.gov processed this record on September 18, 2014