Active Cue-Training in Neglect

Not Applicable

Completed

• Conditions: Hemispatial Neglect
• Interventions: Behavioral: Cueing

• Registration Number: NCT02945592
• Lead Sponsor: Klinikum Bremen Ost

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-19
• Study First Submitted QC: 2016-10-24
• Study First Posted: 2016-10-26
• Primary Completion: 2017-11
• Study Completion: 2018-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-05
• Last Update Posted: 2018-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention	Cueing	* adaptive, therapeutic cueing during reading tasks * adaptive, therapeutic cueing during visuo spatial tasks

Primary Outcome Measures

Name	Time	Method
Change in word and word-part omissions in standardized reading of text and word list	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 Outcome Measures

Name	Time	Method
Change in activities of daily living using the Catherine Bergego Scale	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
Change in Apples Cancellation Task	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
Change in standardized evaluation of the body posture	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.

Trial Locations

Locations (1)

Klinikum Bremen-Ost; 🇩🇪 Bremen, Germany