NCT02945592

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

1.1 years

First QC Date

October 19, 2016

Last Update Submit

March 5, 2018

Conditions

Hemispatial Neglect

Keywords

Hemispatial Neglectcueingegocentric-allocentricearly rehabilitationparietal tDCS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Intervention

EXPERIMENTAL

* adaptive, therapeutic cueing during reading tasks * adaptive, therapeutic cueing during visuo spatial tasks

Behavioral: Cueing

Control

NO INTERVENTION

\- unspecific neglect treatment

Interventions

CueingBEHAVIORAL
Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Previous known dementia
  • Normal pressure hydrocephalus
  • Shunt
  • Craniectomy
  • Epilepsy
  • Other metal implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Bremen-Ost

Bremen, 28325, Germany

Location

MeSH Terms

Conditions

Perceptual Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Helmut Hildebrandt, Prof. Dr.

    Universität Oldenburg, Klinikum Bremen-Ost

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

October 19, 2016

First Posted

October 26, 2016

Study Start

October 1, 2016

Primary Completion

November 1, 2017

Study Completion

January 1, 2018

Last Updated

March 6, 2018

Record last verified: 2018-03

Locations

DE(1)