Active Cue-Training in Neglect

March 5, 2018 updated by: Nergiz Turgut, Klinikum Bremen Ost

The presented study investigates standardized visual cueing in reading and visual spatial task as a treatment method for spatial neglect. In a randomized controlled design patients receive either cued reading and visual spatial tasks (intervention) or treatment which is unspecific to neglect (control).

In the intervention condition, patients with left-sided neglect receive intense training, including reading and visual spatial task with standardized and adapted visual cueing by the therapist. Improvements in reading and visual spatial tasks lead to a reduction of cues by the therapist. Accordingly, the patient has to apply self-cueing over time in order to solve the task.

For the control condition, all patients receive unspecific treatment without any standardized adapted cueing implemented by the therapist.

To enhance the effectivity of cueing in reading and visual spatial tasks, the investigators additionally conduct parietal transcranial direct current stimulation (tDCS) in those patients without tDCS exclusion criteria (see exclusion criteria below).

It is hypothesised that systematic and adaptive therapeutic cueing leads to a significant reduction of omissions of word and word parts in reading.

UPDATE: No Add-on tDCS was performed since it was not applicable for our severly impaired patients due to the strict exclusion criteria of tDCS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bremen, Germany, 28325
        • Klinikum Bremen-Ost

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Left sided neglect
  • Capacity of at least 30 minutes
  • Ability to read in German language
  • Mobilization of 80%

Exclusion Criteria:

  • Previous known dementia
  • Normal pressure hydrocephalus

Exclusion Criteria for tDCS Add-on (not exclusion of the intervention):

  • Shunt
  • Craniectomy
  • Epilepsy
  • Other metal implants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
  • adaptive, therapeutic cueing during reading tasks
  • adaptive, therapeutic cueing during visuo spatial tasks
Behavioral: Cueing
NO_INTERVENTION: Control
- unspecific neglect treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in word and word-part omissions in standardized reading of text and word list
Time Frame: Primary Outcome Measure is assessed two times in the first week (3 days in between), after week 4, after week 7, after week 8
the patient has to read a standardized text of 55 words and a word list of 13 words. Omissions of the complete word and/or of a word part are counted.
Primary Outcome Measure is assessed two times in the first week (3 days in between), after week 4, after week 7, after week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in standardized evaluation of the body posture
Time Frame: Secondary Outcome Measure is assessed two times in the first week (3 days in between), after week 4, after week 7, after week 8
A blinded neurologist evaluates spontaneous and cued body posture (head, eyes, trunk) for ipsilesional, moderate ipsilesional or no deviation.
Secondary Outcome Measure is assessed two times in the first week (3 days in between), after week 4, after week 7, after week 8
Change in Apples Cancellation Task
Time Frame: Secondary Outcome Measure is assessed two times in the first week (3 days in between), after week 4, after week 7, after week 8
a standardized measurement for the evaluation of egocentric and allocentric neglect symptoms
Secondary Outcome Measure is assessed two times in the first week (3 days in between), after week 4, after week 7, after week 8
Change in activities of daily living using the Catherine Bergego Scale
Time Frame: Secondary Outcome Measure is assessed after week 1, after week 4, after week 7, after week 8
The blinded hospital staff evaluates activities of daily living by using the Catherine Bergego scale with specified scoring criteria
Secondary Outcome Measure is assessed after week 1, after week 4, after week 7, after week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinikum Bremen Ost

Investigators

  • Study Director: Helmut Hildebrandt, Prof. Dr., Universität Oldenburg, Klinikum Bremen-Ost

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (ACTUAL)

November 1, 2017

Study Completion (ACTUAL)

January 1, 2018

Study Registration Dates

First Submitted

October 19, 2016

First Submitted That Met QC Criteria

October 24, 2016

First Posted (ESTIMATE)

October 26, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 6, 2018

Last Update Submitted That Met QC Criteria

March 5, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 367915

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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