Clinical trial NCT02945592: Active Cue-Training in Neglect
Official title: Active Cue-Training in Neglect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemispatial Neglect
Keywords: Hemispatial Neglect
cueing
egocentric-allocentric
early rehabilitation
parietal tDCS
Lead sponsor: Klinikum Bremen Ost
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in word and word-part omissions in standardized reading of text and word list
timeFrame: 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:
measure: Change in standardized evaluation of the body posture
timeFrame: Secondary Outcome Measure is assessed two times in the first week (3 days in between), after week 4, after week 7, after week 8
measure: Change in Apples Cancellation Task
timeFrame: Secondary Outcome Measure is assessed two times in the first week (3 days in between), after week 4, after week 7, after week 8
measure: Change in activities of daily living using the Catherine Bergego Scale
timeFrame: Secondary Outcome Measure is assessed after week 1, after week 4, after week 7, after week 8
Other outcomes:
Locations:
city: Bremen
country: Germany
facility: Klinikum Bremen-Ost
Study officials:
affiliation: Universität Oldenburg, Klinikum Bremen-Ost
name: Helmut Hildebrandt, Prof. Dr.
role: STUDY_DIRECTOR
References: