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

Primary Purpose

Hemianopsia

Status
Withdrawn
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Blindsight Training associated to tDCS
Blindsight Training alone
Sponsored by
University of Milano Bicocca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemianopsia focused on measuring tDCS, Visual field, Stroke

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Polo universitario presso I.C. Zucchi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Blindsight training associated to tDCS

Blindsight training alone

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Humphrey visual field 30.2 SITA standard test

Secondary Outcome Measures

Change in Battery for Attentional Performance (TAP) subtest: Visual Field
International Classification of Functioning (ICF)
Change in Schuhfried Vienna Test Peripheral Perception (PP-R)

Full Information

First Posted
October 27, 2016
Last Updated
January 20, 2017
Sponsor
University of Milano Bicocca
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1. Study Identification

Unique Protocol Identification Number
NCT02956668
Brief Title
tDCS Associated to Blindsight Rehabilitation for the Treatment of Homonymous Hemianopsia
Acronym
TABRTHH
Official Title
tDCS Associated to Blindsight Rehabilitation for the Treatment of Homonymous Hemianopsia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Withdrawn
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Milano Bicocca

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemianopsia
Keywords
tDCS, Visual field, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blindsight training associated to tDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
Blindsight training alone
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Blindsight Training associated to tDCS
Intervention Description
The patient undergo visual rehabilitation while his brain is electrically stimulated with tDCS.
Intervention Type
Other
Intervention Name(s)
Blindsight Training alone
Intervention Description
The patient undergo visual rehabilitation
Primary Outcome Measure Information:
Title
Change in Humphrey visual field 30.2 SITA standard test
Time Frame
10 weeks and 20 weeks
Secondary Outcome Measure Information:
Title
Change in Battery for Attentional Performance (TAP) subtest: Visual Field
Time Frame
10 weeks and 20 weeks
Title
International Classification of Functioning (ICF)
Time Frame
20 weeks
Title
Change in Schuhfried Vienna Test Peripheral Perception (PP-R)
Time Frame
10 weeks and 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara M Matteo
Organizational Affiliation
Università degli Studi di Milano - Bicocca
Official's Role
Principal Investigator
Facility Information:
Facility Name
Polo universitario presso I.C. Zucchi
City
Carate Brianza
State/Province
CB
ZIP/Postal Code
20841
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

tDCS Associated to Blindsight Rehabilitation for the Treatment of Homonymous Hemianopsia

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