Active Cue-Training in Neglect

Hemispatial Neglect Clinical Trial

Official title:

Active Cue-Training in Neglect

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02945592
• Other study ID #: 367915
• Status: Completed
• Phase: N/A
• First received: October 19, 2016
• Last updated: March 5, 2018
• Start date: October 2016
• Est. completion date: January 2018

Study information

• Verified date: March 2018
• Source: Klinikum Bremen Ost
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hemispatial Neglect
• Perceptual Disorders

Intervention

Behavioral:
• Cueing

Locations

Country	Name	City	State
Germany	Klinikum Bremen-Ost	Bremen

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum Bremen Ost

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in word and word-part omissions in standardized reading of text and word list	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	Change in standardized evaluation of the body posture	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
Secondary	Change in Apples Cancellation Task	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
Secondary	Change in activities of daily living using the Catherine Bergego Scale	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