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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Recruitment Status : Withdrawn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 6, 2016
Last Update Posted : January 23, 2017
Sponsor:
Information provided by (Responsible Party):
University of Milano Bicocca

Tracking Information
First Submitted Date  ICMJE October 27, 2016
First Posted Date  ICMJE November 6, 2016
Last Update Posted Date January 23, 2017
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
Change in Humphrey visual field 30.2 SITA standard test [ Time Frame: 10 weeks and 20 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE tDCS Associated to Blindsight Rehabilitation for the Treatment of Homonymous Hemianopsia
Official Title  ICMJE tDCS Associated to Blindsight Rehabilitation for the Treatment of Homonymous Hemianopsia
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:

  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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hemianopsia
Intervention  ICMJE
  • Other: Blindsight Training associated to tDCS
    The patient undergo visual rehabilitation while his brain is electrically stimulated with tDCS.
  • Other: Blindsight Training alone
    The patient undergo visual rehabilitation
Study Arms  ICMJE
  • 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.

    Intervention: Other: Blindsight Training associated to 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.

    Intervention: Other: Blindsight Training alone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 20, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 3, 2016)
2
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02956668
Other Study ID Numbers  ICMJE 264-BSTDCS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Milano Bicocca
Study Sponsor  ICMJE University of Milano Bicocca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Barbara M Matteo Università degli Studi di Milano - Bicocca
PRS Account University of Milano Bicocca
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP