BlindnessNCT01754103
Neuroplasticity in Blind Subjects After Repetitive Tactile Stimulation
A study testing Tactile Training in people with Blindness, run by Universidad Complutense de Madrid at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 7 to 70 years
- Conditions the study is for
- Blindness
- What is being tested?
- Tactile Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No history of neurological, psychiatric, cognitive or sensorimotor deficits other than blindness.
Trial locations and contacts
1 site in 1 country.
Laura Ortiz Teran, MD, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Universidad Complutense de Madrid
Madrid, Madrid, 28040
Tomas Ortiz Alonso, MD,PhD, +34 91 394 1495 ext. 1495, tortiz@med.ucm.es
Laura Ortiz Teran, MD, PhD, +1 617 945 3384, teran@nmr.mgh.harvard.edu
About this study
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.
Read the 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.
- Conditions
- Blindness
- Being tested
- Tactile Training
- Keywords
- blind, tactile stimulation, cross-modality, visual qualia, resting state MRI, functional connectivity, neuroplasticity
- Medical subject headings
- Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tactile TrainingOther
Tactile Training to induce neuroplasticity in the visual pathway, measured with functional connectivity MRI
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Tactile Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for BlindnessStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University
- Responsible party
- Principal investigator, Tomas Ortiz Alonso, Universidad Complutense de Madrid
- Investigators
- Tomás Ortiz Alonso, MD PhD, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754103
- Sponsor's protocol ID
- VISION TACTIL
- Status last verified
- Dec 2012
- First submitted
- 2 Jul 2012
- Last updated
- 21 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Pascual-Leone A, Amedi A, Fregni F, Merabet LB. The plastic human brain cortex. Annu Rev Neurosci. 2005;28:377-401. doi: 10.1146/annurev.neuro.27.070203.144216.
PubMed 16022601Feldman DE, Brecht M. Map plasticity in somatosensory cortex. Science. 2005 Nov 4;310(5749):810-5. doi: 10.1126/science.1115807.
PubMed 16272113van Praag H, Christie BR, Sejnowski TJ, Gage FH. Running enhances neurogenesis, learning, and long-term potentiation in mice. Proc Natl Acad Sci U S A. 1999 Nov 9;96(23):13427-31. doi: 10.1073/pnas.96.23.13427.
PubMed 10557337Greenwood RS, Parent JM. Damage control: the influence of environment on recovery from brain injury. Neurology. 2002 Nov 12;59(9):1302-3. doi: 10.1212/wnl.59.9.1302. No abstract available.
PubMed 12427874Lepore N, Voss P, Lepore F, Chou YY, Fortin M, Gougoux F, Lee AD, Brun C, Lassonde M, Madsen SK, Toga AW, Thompson PM. Brain structure changes visualized in early- and late-onset blind subjects. Neuroimage. 2010 Jan 1;49(1):134-40. doi: 10.1016/j.neuroimage.2009.07.048. Epub 2009 Jul 28.
PubMed 19643183Elbert 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.
PubMed 12427851Fortin 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.
PubMed 18854327Sadato 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.
PubMed 8606771Sadato 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.
PubMed 9679774Merabet 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.
PubMed 18728773Burton 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.
PubMed 15449356Wheat 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.
PubMed 7643203Amedi 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.
PubMed 17515898Swisher 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.
PubMed 17507555Harris 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.
PubMed 12351747
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroplasticity in Blind Subjects After Repetitive Tactile Stimulation
- ClinicalTrials.gov ID
- NCT01754103
- Acronym / sponsor ID
- VISION TACTIL
- Conditions
- Blindness
- Keywords
- blind, tactile stimulation, cross-modality, visual qualia, resting state MRI, functional connectivity, neuroplasticity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Harvard University
- Study start
- Jan 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional Connectivity MRI | Experimental | Other: Tactile TrainingFunctional 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. |
Who may qualify
- Ages
- 7 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- No history of neurological, psychiatric, cognitive or sensorimotor deficits other than blindness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tactile TrainingTactile Training to induce neuroplasticity in the visual pathway, measured with functional connectivity MRI | Other | Functional Connectivity MRI |
Primary outcome
MRI Functional Connectivity of the visual pathway
Time frame: 1 year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2012.
- Background: PubMed 16022601Pascual-Leone A, Amedi A, Fregni F, Merabet LB. The plastic human brain cortex. Annu Rev Neurosci. 2005;28:377-401. doi: 10.1146/annurev.neuro.27.070203.144216.
- Background: PubMed 16272113Feldman DE, Brecht M. Map plasticity in somatosensory cortex. Science. 2005 Nov 4;310(5749):810-5. doi: 10.1126/science.1115807.
- Background: PubMed 10557337van Praag H, Christie BR, Sejnowski TJ, Gage FH. Running enhances neurogenesis, learning, and long-term potentiation in mice. Proc Natl Acad Sci U S A. 1999 Nov 9;96(23):13427-31. doi: 10.1073/pnas.96.23.13427.
- Background: PubMed 12427874Greenwood RS, Parent JM. Damage control: the influence of environment on recovery from brain injury. Neurology. 2002 Nov 12;59(9):1302-3. doi: 10.1212/wnl.59.9.1302. No abstract available.
- Background: PubMed 19643183Lepore N, Voss P, Lepore F, Chou YY, Fortin M, Gougoux F, Lee AD, Brun C, Lassonde M, Madsen SK, Toga AW, Thompson PM. Brain structure changes visualized in early- and late-onset blind subjects. Neuroimage. 2010 Jan 1;49(1):134-40. doi: 10.1016/j.neuroimage.2009.07.048. Epub 2009 Jul 28.
- Background: PubMed 12427851Elbert 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.
- Background: PubMed 18854327Fortin 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.
- Background: PubMed 8606771Sadato 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.
- Background: PubMed 9679774Sadato 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.
- Background: PubMed 18728773Merabet 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.
- Background: PubMed 15449356Burton 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.
- Background: PubMed 7643203Wheat 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.
Related trials for Blindness
Recruiting
Ameliorating Stroke-induced Hemianopia Via Multisensory Training
Hemianopia, Homonymous, Cortical Blindness, Unspecified Side of Brain
Not yet recruiting
Multisensory Rehabilitation of Vision Loss After Cortical Damage
Cortical Blindness
Not yet recruiting
Remapping Text in Sentence and Word Tasks to Aid Reading With Central Vision Loss
Macular Degeneration, Central Visual Impairment
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Ortiz Teran, MD, PhD contact
Tomás Ortiz Alonso, MD PhD principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tactile Training in people with Blindness, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tomas Ortiz Alonso, MD, PhD (+34 91 394 1495, tortiz@med.ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI Functional Connectivity of the visual pathway (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01754103, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2012; AzTrials last refreshed its copy on 6 Nov 2026.