Spatial NeglectNibsNeglectNCT05466487

Non-Invasive Brain Stimulation as an Innovative Treatment for Chronic Neglect Patients

A study testing Transcranial Alternating Current Stimulation (tACS) and Visual Scanning Training (VST) in people with Spatial Neglect, run by Maastricht University at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Spatial Neglect
What is being tested?: Transcranial Alternating Current Stimulation (tACS) and Visual Scanning Training (VST)
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 1 siteNetherlands
Study dates: 21 Oct 2020to 24 Mar 2023
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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

neurologically objectified stroke;
stroke occurred when patient was 18-80 years of age;
chronic stroke (>6 months post-stroke onset);
sufficient comprehension and communication skills to benefit from training (based on clinical judgement); and
a screening containing four neuropsychological tests will be performed to evaluate the current severity of the neglect, since the diagnosis of neglect may have been established months or even years ago in our sample of chronic stroke patients.

Who cannot join

currently engaging in cognitive rehabilitation treatment or neglect treatment;
physically or mentally unable to participate (based on clinical judgment);
hemianopsia (based on clinical judgement);
severe communicative disability, as task descriptions need to be understood;
local scalp injuries*;
eczema on scalp or psoriasis*;

Show all 10Show fewer

diagnosed (neuro)psychiatric or neurodegenerative diseases*;
current alcohol and/or drug abuse*; and
pregnancy*.
due to tACS safety considerations.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Maastricht University
Maastricht, Limburg, 6200 MD

Other trials in Netherlands

About this study

Official title: Transcranial Alternating Stimulation in Rehabilitation: a Randomized Controlled Trial in Chronic Stroke Patients With Visuospatial Neglect

Background Stroke is a leading cause of neurological impairments in language, motor and cognitive functions. Next to traditional stroke treatment, Non-Invasive Brain Stimulation (NIBS) offers the potential to facilitate stroke recovery as a complementary approach. Here, we aim at exploiting the principles of NIBS, specifically transcranial Alternating Current Stimulation (tACS), to promote functional recovery of people with neglect symptoms following stroke.

Objective To determine whether neglect training complemented with tACS treatment in chronic stroke patients suffering from neglect improves neglect-related symptoms compared to neglect training with sham stimulation.

Study design Double-blind randomized placebo-controlled intervention study. After enrollment and completion of baseline measurements, participants are randomly assigned to either the active tACS group or sham (control) group.

Intervention We will combine an evidence based visual scanning training (VST) with 40 minutes of (active or sham) tACS at alpha frequency. The intervention is administered three times a week for a duration of six weeks.

Outcomes of the study Performance on standard, conventional neuropsychological tests, as well as on ADL observation scales.

Conditions: Spatial Neglect
Being tested: Transcranial Alternating Current Stimulation (tACS), Visual Scanning Training (VST)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial Alternating Current Stimulation (tACS)Device
Stimulation frequency and peak-to-peak intensity will be set to 10Hz and 1.5 milliampere (mA), phase offset will be set to 0 and 100 cycles will be used for ramping up. At the start of the neglect training session, the tACS will be started. When the neglect training session is finished, after maximally 40 minutes, the tACS will be switched off.
Visual Scanning Training (VST)Behavioural
The most common treatment for neglect is VST, which is an intensive compensation training (see Dutch guidelines for rehabilitation of neglect: Ten Brink, Van Kessel, \& Nijboer, 2017). The aim of this training is to improve visual scanning behavior, that is, to encourage neglect patients to actively and consciously pay attention to stimuli on the contralesional side.

Study groups in NCT05466487
Study group	Role	What they receive
Active tACS	Experimental	Not described Receives: Device: Transcranial Alternating Current Stimulation (tACS); Behavioral: Visual Scanning Training (VST)
Sham tACS	Sham comparator	Not described Receives: Device: Transcranial Alternating Current Stimulation (tACS); Behavioral: Visual Scanning Training (VST)

What is being measured

The primary outcome is the main question the study is designed to answer.

Star Cancellation Task
Quality of search score
Measured: Testing will take place before the training (T0; baseline), after the first (T1), ninth (T2), and eighteenth (T3) training session, as well as one week (T4) and three months (T5) after termination of the training.

Secondary outcomes (6)

Computerized Visual Detection Task
Sum of weighted hits
Measured: Testing will take place before the training (T0; baseline), after the first (T1), ninth (T2), and eighteenth (T3) training session, as well as one week (T4) and three months (T5) after termination of the training.
McIntosh Line Bisection Task-digitized
Endpoint weightings bias
Measured: Testing will take place before the training (T0; baseline), after the first (T1), ninth (T2), and eighteenth (T3) training session, as well as one week (T4) and three months (T5) after termination of the training.
Schenkenberg Line Bisection Task
Relative deviation score
Measured: Testing will take place before the training (T0; baseline), after the first (T1), ninth (T2), and eighteenth (T3) training session, as well as one week (T4) and three months (T5) after termination of the training.
Baking Tray Task
Average x-coordinate
Measured: Testing will take place before the training (T0; baseline), after the ninth (T2) training session, as well as one week (T4) and three months (T5) after termination of the training.
Catherine Bergego Scale
Total score. The CBS is a 10-item observation scale, and results in a total score of 0 (no neglect) to 30 (severe neglect).
Measured: Testing will take place before the training (T0; baseline), after the ninth (T2) training session, as well as one week (T4) and three months (T5) after termination of the training.
Subjective Neglect Questionnaire
Total score. The SNQ is a 19-item questionnaire, and results in a total score of 19 (no reported problems) to 95 (many/frequently reported problems).
Measured: Testing will take place before the training (T0; baseline), after the ninth (T2) training session, as well as one week (T4) and three months (T5) after termination of the training.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Oct 202024 Mar 2023

First posted20 Jul 2022
Study start21 Oct 2020
Primary completion24 Mar 2023
Study completion24 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Spatial 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: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05466487
Sponsor's protocol ID: NL70256.068.19
Acronym: NibsNeglect
Status last verified: Oct 2023
First submitted: 18 Jul 2022
Last updated: 26 Oct 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Middag-van Spanje M, Nijboer TCW, Schepers J, van Heugten C, Sack AT, Schuhmann T. Alpha transcranial alternating current stimulation as add-on to neglect training: a randomized trial. Brain Commun. 2024 Aug 30;6(5):fcae287. doi: 10.1093/braincomms/fcae287. eCollection 2024.
PubMed 39301290
Middag-van Spanje M, Schuhmann T, Nijboer T, van der Werf O, Sack AT, van Heugten C. Study protocol of transcranial electrical stimulation at alpha frequency applied during rehabilitation: A randomized controlled trial in chronic stroke patients with visuospatial neglect. BMC Neurol. 2022 Nov 2;22(1):402. doi: 10.1186/s12883-022-02932-7.
PubMed 36324088

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Immersive Virtual Reality Treatment for Unilateral Spatial Neglect
Stroke, Unilateral Spatial Neglect
Not yet recruiting
Dosing and Deployment Trial: A Home-based Optokinetic Treatment
Spatial Neglect
Recruiting
Strategy Training for Optimizing Attention for Individuals With Spatial Neglect
Stroke, Neglect, Hemispatial
Recruiting
Prism Adaptation Therapy (PAT) for Right Brain Stroke Rehabilitation
Spatial Neglect After Right Brain Stroke
Not yet recruitingObservational study
Validation of Web-Based Star Cancellation and Line Bisection Tests in Hemiplegic Stroke
Stroke, Spatial Neglect

All Spatial Neglect trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Transcranial Alternating Stimulation in Rehabilitation: a Randomized Controlled Trial in Chronic Stroke Patients With Visuospatial Neglect
ClinicalTrials.gov ID: NCT05466487
Acronym / sponsor ID: NibsNeglect / NL70256.068.19
Conditions: Spatial Neglect
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Maastricht UniversityUniversity, hospital or other
Study start: 21 Oct 2020 (actual)
Primary completion: 24 Mar 2023 (actual)
Study completion: 24 Mar 2023 (actual)
First posted: 20 Jul 2022 (actual)
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.

Outcomes of the study Performance on standard, conventional neuropsychological tests, as well as on ADL observation scales.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active tACS	Experimental	Device: Transcranial Alternating Current Stimulation (tACS), Behavioral: Visual Scanning Training (VST)
Sham tACS	Sham comparator	Device: Transcranial Alternating Current Stimulation (tACS), Behavioral: Visual Scanning Training (VST)

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

neurologically objectified stroke;
stroke occurred when patient was 18-80 years of age;
chronic stroke (>6 months post-stroke onset);
sufficient comprehension and communication skills to benefit from training (based on clinical judgement); and
a screening containing four neuropsychological tests will be performed to evaluate the current severity of the neglect, since the diagnosis of neglect may have been established months or even years ago in our sample of chronic stroke patients.

Key exclusion criteria (10 listed)

currently engaging in cognitive rehabilitation treatment or neglect treatment;
physically or mentally unable to participate (based on clinical judgment);
hemianopsia (based on clinical judgement);
severe communicative disability, as task descriptions need to be understood;
local scalp injuries*;

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
Transcranial Alternating Current Stimulation (tACS)Stimulation frequency and peak-to-peak intensity will be set to 10Hz and 1.5 milliampere (mA), phase offset will be set to 0 and 100 cycles will be used for ramping up. At the start of the neglect training session, the tACS will be started. When the neglect training session is finished, after maximally 40 minutes, the tACS will be switched off.	Device	Active tACS, Sham tACS
Visual Scanning Training (VST)The most common treatment for neglect is VST, which is an intensive compensation training (see Dutch guidelines for rehabilitation of neglect: Ten Brink, Van Kessel, \& Nijboer, 2017). The aim of this training is to improve visual scanning behavior, that is, to encourage neglect patients to actively and consciously pay attention to stimuli on the contralesional side.	Behavioural	Active tACS, Sham tACS

Primary outcome

Star Cancellation Task
Time frame: Testing will take place before the training (T0; baseline), after the first (T1), ninth (T2), and eighteenth (T3) training session, as well as one week (T4) and three months (T5) after termination of the training.
Quality of search score

6 secondary outcomes

Computerized Visual Detection Task
Time frame: Testing will take place before the training (T0; baseline), after the first (T1), ninth (T2), and eighteenth (T3) training session, as well as one week (T4) and three months (T5) after termination of the training.
McIntosh Line Bisection Task-digitized
Time frame: Testing will take place before the training (T0; baseline), after the first (T1), ninth (T2), and eighteenth (T3) training session, as well as one week (T4) and three months (T5) after termination of the training.
Schenkenberg Line Bisection Task
Time frame: Testing will take place before the training (T0; baseline), after the first (T1), ninth (T2), and eighteenth (T3) training session, as well as one week (T4) and three months (T5) after termination of the training.
Baking Tray Task
Time frame: Testing will take place before the training (T0; baseline), after the ninth (T2) training session, as well as one week (T4) and three months (T5) after termination of the training.
Catherine Bergego Scale
Time frame: Testing will take place before the training (T0; baseline), after the ninth (T2) training session, as well as one week (T4) and three months (T5) after termination of the training.
Subjective Neglect Questionnaire
Time frame: Testing will take place before the training (T0; baseline), after the ninth (T2) training session, as well as one week (T4) and three months (T5) after termination of the training.

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 26 Oct 2023.
Derived from this study: PubMed 39301290Middag-van Spanje M, Nijboer TCW, Schepers J, van Heugten C, Sack AT, Schuhmann T. Alpha transcranial alternating current stimulation as add-on to neglect training: a randomized trial. Brain Commun. 2024 Aug 30;6(5):fcae287. doi: 10.1093/braincomms/fcae287. eCollection 2024.
Derived from this study: PubMed 36324088Middag-van Spanje M, Schuhmann T, Nijboer T, van der Werf O, Sack AT, van Heugten C. Study protocol of transcranial electrical stimulation at alpha frequency applied during rehabilitation: A randomized controlled trial in chronic stroke patients with visuospatial neglect. BMC Neurol. 2022 Nov 2;22(1):402. doi: 10.1186/s12883-022-02932-7.
Individual participant dataSharing planned: No

Related trials for Spatial Neglect

Recruiting
Immersive Virtual Reality Treatment for Unilateral Spatial Neglect
Stroke, Unilateral Spatial Neglect
Not yet recruiting
Dosing and Deployment Trial: A Home-based Optokinetic Treatment
Spatial Neglect
Recruiting
Strategy Training for Optimizing Attention for Individuals With Spatial Neglect
Stroke, Neglect, Hemispatial
Recruiting
Prism Adaptation Therapy (PAT) for Right Brain Stroke Rehabilitation
Spatial Neglect After Right Brain Stroke
Not yet recruitingObservational study
Validation of Web-Based Star Cancellation and Line Bisection Tests in Hemiplegic Stroke
Stroke, Spatial Neglect

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.

Alexander T. Sack, PhD principal investigator

Maastricht University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Alternating Current Stimulation (tACS) and Visual Scanning Training (VST) in people with Spatial Neglect, run by Maastricht University at 1 site in Netherlands.

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 5 inclusion and 10 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 26 Oct 2023. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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?

Star Cancellation Task (time frame: Testing will take place before the training (T0; baseline), after the first (T1), ninth (T2), and eighteenth (T3) training session, as well as one week (T4) and three months (T5) after termination of the training.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05466487, which also lists 2 linked publications.

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 26 Oct 2023.