HemianopsiaTABRTHHNCT02956668
tDCS Associated to Blindsight Rehabilitation for the Treatment of Homonymous Hemianopsia
A study testing Blindsight Training associated to tDCS and Blindsight Training alone in people with Hemianopsia, run by University of Milano Bicocca at 1 site in Italy.
Trial summary
Homonymous hemianopia is one of the most common symptoms following a neurologic damage and has many negative effects on functional abilities and daily activities. There are two main kind of restorative rehabilitation of hemianopia: "border training", which involves exercising vision at the edge of the damaged visual… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemianopsia
- What is being tested?
- Blindsight Training associated to tDCS and Blindsight Training alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2016to Dec 2017
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is able to give his informed consent
- Stroke
- Hemianopsia brain damage documented by means of TAC or RMN
- Hemianopsia diagnosed by means automated visual field and Neurological Evaluation
- Time from lesion at least six months
- normal or corrected-to-normal visual acuity
Who cannot join
- Presence of Ophthalmologic neuropsychologic or psychiatric pathology
- Global cognitive deficit,
- Presence of other neurological pathology
- Presence of cardiac peacemaker
- Presence metallic or electronic items in the head or in the body
- Story/familiarity of epilepsy, taking medications that can induce epileptic crisis
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- Severe heart disease
- History of high alcohol consumption
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Homonymous hemianopia is one of the most common symptoms following a neurologic damage and has many negative effects on functional abilities and daily activities.
There are two main kind of restorative rehabilitation of hemianopia: "border training", which involves exercising vision at the edge of the damaged visual field, and "blindsight training", which is based on exercising the unconscious perceptual functions in the mild of the blind hemifield.
Read more
In literature only border training effects were shown to be facilitated by transcranial direct current stimulation (tDCS).
The investigators treat two patients with blindsight rehabilitation associated to tDCS over parieto-occipital cortex. The two patients undergo a cycle of blindsight treatment associated to tDCS and a cycle of blindsight training alone in inverted order.
Aim of the study is to investigate if the anodic stimulation of perilesional areas enhance the improvement induced by blindsight rehabilitation treatment.
Read the detailed description
The study design is a crossover AB BA. Treatment A consist in a cycle of blindsight training associated to tDCS, Treatment B consist in a a cycle of blindsight training alone.
During the blindsight training, the patient is asked to maintain central fixation and is exposed to visual stimuli in his blind hemifield. The patient task is detection and/or discrimination of stimuli.
During each session the patient is subjected to around 700 different stimuli variously associated in space and/or time.
One out of two blindsight training cycles is associated to tDCS treatment. Anodal tDCS is applied using a battery-driven constant current stimulator, and a pair of surface saline-soaked sponge electrodes (5 x 5 cm). Current intensity is of 2 mA (Fade-in/-out= 10 sec), for a total duration of 30 min. The stimulation start at the beginning of the rehabilitation session, and continue for 30 min, during treatment.
Anode is placed over the parieto-occipital cortex. The cathode is placed in the contralateral supraorbital position.
To assess the actual improvement patients performed:
- Clinical-instrumental assessment: Threshold visual field Humphrey SITA-standard 30-2 program is used to measure the visual perception within the central 30 degrees.
- Peripheral visual field test Schofield Vienna PP-R test is used to measure the visual perception up to 180 degrees. A double task in central vision was performed in order to verify test reliability.
- Functional visual field assessment: Test for Attention Performance (TAP - v. 2.3) visual field 92 stimuli subtest (26) is performed.
- Ecological assessment: during initial and final interview an ICF profile of the subject is edited. The profile includes mainly the Activity and Participation categories of ICF.
All these investigations is performed before the treatment and after each cycle
- Conditions
- Hemianopsia
- Being tested
- Blindsight Training associated to tDCS, Blindsight Training alone
- Keywords
- tDCS, Visual field, Stroke
- Medical subject headings
- Hemianopsia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blindsight Training associated to tDCSOther
The patient undergo visual rehabilitation while his brain is electrically stimulated with tDCS.
Blindsight Training aloneOther
The patient undergo visual rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Blindsight training associated to tDCS | Experimental | During the blindsight training (one-hour time), the patient is asked to maintain central fixation and is exposed to visual stimuli in his blind hemifield. The patient task is detection and/or discrimination of stimuli.
During each session the patient is subjected to around 700 different stimuli variously associated in space and/or time.
tDCS stimulation start at the beginning of the rehabilitation session, and continue for 30 min, during treatment.
Anode is placed over the parieto-occipital cortex. The cathode is placed in the contralateral supraorbital position. Receives: Other: Blindsight Training associated to tDCS |
| Blindsight training alone | Active comparator | During the blindsight training (one-hour time), the patient is asked to maintain central fixation and is exposed to visual stimuli in his blind hemifield. The patient task is detection and/or discrimination of stimuli.
During each session the patient is subjected to around 700 different stimuli variously associated in space and/or time. Receives: Other: Blindsight Training alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Humphrey visual field 30.2 SITA standard test
Measured: 10 weeks and 20 weeks
Secondary outcomes (3)
Change in Battery for Attentional Performance (TAP) subtest: Visual Field
Measured: 10 weeks and 20 weeks
International Classification of Functioning (ICF)
Measured: 20 weeks
Change in Schuhfried Vienna Test Peripheral Perception (PP-R)
Measured: 10 weeks and 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemianopsiaStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara M Matteo, Principal investigator, Università degli Studi di Milano - Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956668
- Sponsor's protocol ID
- 264-BSTDCS
- Acronym
- TABRTHH
- Status last verified
- Jan 2017
- First submitted
- 27 Oct 2016
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- tDCS Associated to Blindsight Rehabilitation for the Treatment of Homonymous Hemianopsia
- ClinicalTrials.gov ID
- NCT02956668
- Acronym / sponsor ID
- TABRTHH / 264-BSTDCS
- Conditions
- Hemianopsia
- Keywords
- tDCS, Visual field, Stroke
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 7 Nov 2016 (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.
Homonymous hemianopia is one of the most common symptoms following a neurologic damage and has many negative effects on functional abilities and daily activities.
There are two main kind of restorative rehabilitation of hemianopia: "border training", which involves exercising vision at the edge of the damaged visual field, and "blindsight training", which is based on exercising the unconscious perceptual functions in the mild of the blind hemifield.
In literature only border training effects were shown to be facilitated by transcranial direct current stimulation (tDCS).
The investigators treat two patients with blindsight rehabilitation associated to tDCS over parieto-occipital cortex. The two patients undergo a cycle of blindsight treatment associated to tDCS and a cycle of blindsight training alone in inverted order.
Aim of the study is to investigate if the anodic stimulation of perilesional areas enhance the improvement induced by blindsight rehabilitation treatment.
Detailed description
The study design is a crossover AB BA. Treatment A consist in a cycle of blindsight training associated to tDCS, Treatment B consist in a a cycle of blindsight training alone.
During the blindsight training, the patient is asked to maintain central fixation and is exposed to visual stimuli in his blind hemifield. The patient task is detection and/or discrimination of stimuli.
During each session the patient is subjected to around 700 different stimuli variously associated in space and/or time.
One out of two blindsight training cycles is associated to tDCS treatment. Anodal tDCS is applied using a battery-driven constant current stimulator, and a pair of surface saline-soaked sponge electrodes (5 x 5 cm). Current intensity is of 2 mA (Fade-in/-out= 10 sec), for a total duration of 30 min. The stimulation start at the beginning of the rehabilitation session, and continue for 30 min, during treatment.
Anode is placed over the parieto-occipital cortex. The cathode is placed in the contralateral supraorbital position.
To assess the actual improvement patients performed:
- Clinical-instrumental assessment: Threshold visual field Humphrey SITA-standard 30-2 program is used to measure the visual perception within the central 30 degrees.
- Peripheral visual field test Schofield Vienna PP-R test is used to measure the visual perception up to 180 degrees. A double task in central vision was performed in order to verify test reliability.
- Functional visual field assessment: Test for Attention Performance (TAP - v. 2.3) visual field 92 stimuli subtest (26) is performed.
- Ecological assessment: during initial and final interview an ICF profile of the subject is edited. The profile includes mainly the Activity and Participation categories of ICF.
All these investigations is performed before the treatment and after each cycle
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blindsight training associated to tDCS | Experimental | Other: Blindsight Training associated to tDCSDuring the blindsight training (one-hour time), the patient is asked to maintain central fixation and is exposed to visual stimuli in his blind hemifield. The patient task is detection and/or discrimination of stimuli. During each session the patient is subjected to around 700 different stimuli variously associated in space and/or time. tDCS stimulation start at the beginning of the rehabilitation session, and continue for 30 min, during treatment. Anode is placed over the parieto-occipital cortex. The cathode is placed in the contralateral supraorbital position. |
| Blindsight training alone | Active comparator | Other: Blindsight Training aloneDuring the blindsight training (one-hour time), the patient is asked to maintain central fixation and is exposed to visual stimuli in his blind hemifield. The patient task is detection and/or discrimination of stimuli. During each session the patient is subjected to around 700 different stimuli variously associated in space and/or time. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subject is able to give his informed consent
- Stroke
- Hemianopsia brain damage documented by means of TAC or RMN
- Hemianopsia diagnosed by means automated visual field and Neurological Evaluation
- Time from lesion at least six months
Key exclusion criteria (9 listed)
- Presence of Ophthalmologic neuropsychologic or psychiatric pathology
- Global cognitive deficit,
- Presence of other neurological pathology
- Presence of cardiac peacemaker
- Presence metallic or electronic items in the head or in the body
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 |
|---|---|---|
| Blindsight Training associated to tDCSThe patient undergo visual rehabilitation while his brain is electrically stimulated with tDCS. | Other | Blindsight training associated to tDCS |
| Blindsight Training aloneThe patient undergo visual rehabilitation | Other | Blindsight training alone |
Primary outcome
Change in Humphrey visual field 30.2 SITA standard test
Time frame: 10 weeks and 20 weeks
3 secondary outcomes
Change in Battery for Attentional Performance (TAP) subtest: Visual Field
Time frame: 10 weeks and 20 weeks
International Classification of Functioning (ICF)
Time frame: 20 weeks
Change in Schuhfried Vienna Test Peripheral Perception (PP-R)
Time frame: 10 weeks and 20 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Hemianopsia
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Not yet recruiting
Multisensory Rehabilitation of Vision Loss After Cortical Damage
Cortical Blindness
Recruiting
Ameliorating Stroke-induced Hemianopia Via Multisensory Training
Hemianopia, Homonymous, Cortical Blindness, Unspecified Side of Brain
Active, not recruiting
Statistical Learning as a Novel Intervention for Cortical Blindness
Stroke, Ischemic, Hemianopia, Homonymous
Not yet recruitingObservational study
Anatomical and Functional Predictions of Blindsight Capabilities in Patients With Lateral Hemianopsia
Homonymous Hemianopia, Stroke
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.
Barbara M Matteo principal investigator
Università degli Studi di Milano - Bicocca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blindsight Training associated to tDCS and Blindsight Training alone in people with Hemianopsia, run by University of Milano Bicocca at 1 site in Italy.
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 6 inclusion and 9 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: withdrawn, as of the sponsor's last update on 23 Jan 2017. 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 Italy. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Humphrey visual field 30.2 SITA standard test (time frame: 10 weeks and 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2017.