Neuroplasticity in Blind Subjects After Repetitive Tactile Stimulation

Blindness Clinical Trial

Official title:

Neuroplasticity in Blind Subjects After Repetitive Tactile Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01754103
• Other study ID #: VISION TACTIL
• Status: Recruiting
• Phase: N/A
• First received: July 2, 2012
• Last updated: December 17, 2012
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2012
• Source: Universidad Complutense de Madrid
• Contact: Tomas Ortiz Alonso, MD, PhD
• Phone: +34 91 394 1495
• Email: tortiz[@]med.ucm.es
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 70 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Blindness

Intervention

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

Locations

Country	Name	City	State
Spain	Universidad Complutense de Madrid	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	Harvard University

Country where clinical trial is conducted

Spain, 

References & Publications (22)

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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. Epub 2006 Aug 3. — View Citation

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. — View Citation

Pascual-Leone A, Amedi A, Fregni F, Merabet LB. The plastic human brain cortex. Annu Rev Neurosci. 2005;28:377-401. Review. — View Citation

Sadato N, Pascual-Leone A, Grafman J, Deiber MP, Ibañez V, Hallett M. Neural networks for Braille reading by the blind. Brain. 1998 Jul;121 ( Pt 7):1213-29. — View Citation

Sadato N, Pascual-Leone A, Grafman J, Ibañez 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. — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No