Hemispatial NeglectNCT02945592
Active Cue-Training in Neglect
A study testing Cueing in people with Hemispatial Neglect, run by Klinikum Bremen Ost at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemispatial Neglect
- What is being tested?
- Cueing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2016to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Left sided neglect
- Capacity of at least 30 minutes
- Ability to read in German language
- Mobilization of 80%
Who cannot join
- Previous known dementia
- Normal pressure hydrocephalus
- Exclusion Criteria for tDCS Add-on (not exclusion of the intervention):
- Shunt
- Craniectomy
- Epilepsy
- Other metal implants
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Hemispatial Neglect
- Being tested
- Cueing
- Keywords
- Hemispatial Neglect, cueing, egocentric-allocentric, early rehabilitation, parietal tDCS
- Medical subject headings
- Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CueingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | * adaptive, therapeutic cueing during reading tasks
* adaptive, therapeutic cueing during visuo spatial tasks Receives: Behavioral: Cueing |
| Control | No intervention | - unspecific neglect treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
A blinded neurologist evaluates spontaneous and cued body posture (head, eyes, trunk) for ipsilesional, moderate ipsilesional or no deviation.
Measured: 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
a standardized measurement for the evaluation of egocentric and allocentric neglect symptoms
Measured: 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
The blinded hospital staff evaluates activities of daily living by using the Catherine Bergego scale with specified scoring criteria
Measured: Secondary Outcome Measure is assessed after week 1, after week 4, after week 7, after week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemispatial NeglectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum Bremen Ost
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nergiz Turgut, Klinikum Bremen Ost
- Investigators
- Helmut Hildebrandt, Prof. Dr., Study director, Universität Oldenburg, Klinikum Bremen-Ost
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945592
- Sponsor's protocol ID
- 367915
- Status last verified
- Mar 2018
- First submitted
- 19 Oct 2016
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Cue-Training in Neglect
- ClinicalTrials.gov ID
- NCT02945592
- Acronym / sponsor ID
- 367915
- Conditions
- Hemispatial Neglect
- Keywords
- Hemispatial Neglect, cueing, egocentric-allocentric, early rehabilitation, parietal tDCS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Klinikum Bremen OstUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Nov 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Cueing* adaptive, therapeutic cueing during reading tasks * adaptive, therapeutic cueing during visuo spatial tasks |
| Control | No intervention | –- unspecific neglect treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Left sided neglect
- Capacity of at least 30 minutes
- Ability to read in German language
- Mobilization of 80%
Key exclusion criteria (7 listed)
- Previous known dementia
- Normal pressure hydrocephalus
- Shunt
- Craniectomy
- Epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cueing | Behavioural | Intervention |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Hemispatial Neglect
Recruiting
Implementation of IVS3 for Upper Limb Motor Recovery
Neglect, Hemispatial, Stroke, Cardiovascular
Not yet recruitingObservational study
Motor Imaging, Neglect, and Upper Extremity Function in Stroke
Stroke, Neglect, Hemispatial
Not yet recruiting
Cerebellum and Neglect
Hemispatial Neglect, Visual Neglect
Recruiting
Strategy Training for Optimizing Attention for Individuals With Spatial Neglect
Stroke, Neglect, Hemispatial
Enrolling by invitation
Effectiveness of an Interactive Screen in the Rehabilitation of Neglect in Adults With Subacute Stroke: A Randomized Controlled Trial in Argentina.
Stroke, Neglect, Hemispatial
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helmut Hildebrandt, Prof. Dr. study director
Universität Oldenburg, Klinikum Bremen-Ost
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cueing in people with Hemispatial Neglect, run by Klinikum Bremen Ost at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2018.