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tDCS Associated to Blindsight Rehabilitation for the Treatment of Homonymous Hemianopsia (TABRTHH)

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ClinicalTrials.gov Identifier: NCT02956668
Recruitment Status : Withdrawn
First Posted : November 7, 2016
Last Update Posted : January 23, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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 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.


Condition or disease Intervention/treatment
Hemianopsia Other: Blindsight Training associated to tDCS Other: Blindsight Training alone

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:

  1. Clinical-instrumental assessment: Threshold visual field Humphrey SITA-standard 30-2 program is used to measure the visual perception within the central 30 degrees.
  2. 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.
  3. Functional visual field assessment: Test for Attention Performance (TAP - v. 2.3) visual field 92 stimuli subtest (26) is performed.
  4. 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: tDCS Associated to Blindsight Rehabilitation for the Treatment of Homonymous Hemianopsia
Study Start Date : September 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Blindsight training associated to tDCS

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.

Other: Blindsight Training associated to tDCS
The patient undergo visual rehabilitation while his brain is electrically stimulated with tDCS.
Active Comparator: Blindsight training alone

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.

Other: Blindsight Training alone
The patient undergo visual rehabilitation


Outcome Measures

Primary Outcome Measures :
  1. Change in Humphrey visual field 30.2 SITA standard test [ Time Frame: 10 weeks and 20 weeks ]

Secondary Outcome Measures :
  1. Change in Battery for Attentional Performance (TAP) subtest: Visual Field [ Time Frame: 10 weeks and 20 weeks ]
  2. International Classification of Functioning (ICF) [ Time Frame: 20 weeks ]
  3. Change in Schuhfried Vienna Test Peripheral Perception (PP-R) [ Time Frame: 10 weeks and 20 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Severe heart disease
  • History of high alcohol consumption
  • Pregnancy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956668


Locations
Italy
Polo universitario presso I.C. Zucchi
Carate Brianza, CB, Italy, 20841
Sponsors and Collaborators
University of Milano Bicocca
Investigators
Principal Investigator: Barbara M Matteo Università degli Studi di Milano - Bicocca
More Information

Responsible Party: University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT02956668     History of Changes
Other Study ID Numbers: 264-BSTDCS
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of Milano Bicocca:
tDCS
Visual field
Stroke

Additional relevant MeSH terms:
Hemianopsia
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Blindness
Eye Diseases
Signs and Symptoms