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OpenTrials
Completed

NCT Number: NCT02945592

Active Cue-Training in Neglect

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Bremen-Ost

Bremen, 28325, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cueing

Behavioral

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Klinikum Bremen Ost

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Oct 26, 2016
Registry last updated
Mar 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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