Cardiac ArrestBROCA-NIBSNCT06119620
Modifying Working Memory With Brain Stimulation
A study testing intermitted theta burst stimulation in people with Cardiac Arrest and Cognitive Impairment, run by Maastricht University at 1 site in Netherlands.
Trial summary
The investigators want to investigate the effect of rTMS on working memory measured by the N-back task. This is a single case experimental design, ABAB. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest, Cognitive Impairment
- What is being tested?
- intermitted theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2023to 1 Oct 2024
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Had a cardiac arrest between 3 months and 5 years prior to the experiment session.
- Scores lower than the general population (corrected for age, education, and sex) on at least one of the cognitive tests ( SD < -1 on the Stroop, digit span, or TMT).
- Age 18 up to and including 75.
- Proficient in Dutch or English to understand the instructions for the N-back task.
- Has sufficient understanding to perform the N-back task.
- Written informed consent
Who cannot join
- Has a pacemaker or ICD (implantable cardioverter-defibrillator)
- A history or a family member with a history of seizures / epilepsy (asked on the phone and checked on the first appointment).
- Metal implants in or near the head.
- Pregnancy
- Any other neurological disorder impending working memory performance besides the OHCA.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University
Maastricht, Limburg
Pauline van Gils, Drs., 0031433884095, c.vangils@maastrichtuniversity.nl
Caroline van Heugten, Prof. Dr., +31-43-3884090, caroline.vanheugten@maastrichtuniversity.nl
About this study
Official title: Brain Outcome After Cardiac Arrest. Modifying Working Memory With Non-invasive Brain Stimulation - A Series of SCEDs
The investigators want to investigate the effect of rTMS on working memory measured by the N-back task. This is a single case experimental design, ABAB.
Read the detailed description
Rationale: The survival rate of patients after cardiac arrest and resuscitation has increased considerably. A common consequence of cardiac arrest is ischemic-hypoxic brain damage leading to cognitive impairment. Currently, there is a lack of knowledge regarding effectiveness of treatments to improve outcomes of patients with cognitive impairment after a cardiac arrest.
Objective: The primary objective is to investigate the effects of rTMS (iTBS protocol) on working memory of people with memory impairments after a cardiac arrest in the past Study design: This will be a single blinded replicated randomized SCED withdrawal designs study.
Study population: Nine adults who had a cardiac arrest in the past will be participating in this study. They are recruited in the general population.
Intervention: If participants are suitable based on the screening. Participants are invited to the university of Maastricht. There they receive intermitted theta burst stimulation with a TMS coil for 3 minutes on the dorsolateral prefrontal cortex. Then they perform the N-back task for 8 to 12 minutes to estimate working-memory performance. Then they have a break (45 min). Then they receive 3 minutes of sham stimulation after which they have to perform the N-back task again for 8 - 12 minutes. This will be repeated (active stimulation - sham - active stimulation - sham).
Main study parameter: The main study outcomes are performance on the N-back task with regard to accuracy.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The participant has to come to the university twice. The screening session takes approximately 1-1,5 hour, the experimental session 3,5 hours. The participant could experience side effects of the rTMS, these include: headache, scalp discomfort, tingling or twitching of the facial muscles, and light-headedness. Serious side effects are very rare, but they may include: seizures. The N-back task can be experienced as tiring.
- Conditions
- Cardiac Arrest, Cognitive Impairment
- Being tested
- intermitted theta burst stimulation
- Medical subject headings
- Heart Arrest, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermitted theta burst stimulationDevice
Also called rTMS
Participants receive intermitted theta burst stimulation for 3-4 minutes before completing the N-back task.
| Study group | Role | What they receive |
|---|---|---|
| ABAB | Other | all participants will go through sham (control) and active (experimental) stimulation. So either sham - active - sham - active or active - sham - active - sham Receives: Device: intermitted theta burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy on the N-back task
Percentage of correct responses for every 2 N-back blocks
Measured: 1 measurements every 2 minutes for 8 - 10 minutes after each N-back task (4 times in total)
Secondary outcomes (2)
RT on the N-back task
reaction time on the N-back task
Measured: 1 measurements every 2 minutes for 8 - 10 minutes after each N-back task (4 times in total)
d' on the N-back task
d' = z(False alarms) - z(Hits)
Measured: 1 measurements every 2 minutes for 8 - 10 minutes after each N-back task (4 times in total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Nov 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single case experimental design. All participants will receive both sham and active stimulation. The order of stimulation (sham, active, sham active OR active, sham, active, sham) will be randomised. Also the length of the N-back task is randomised between 8, 10, and 12 minutes).
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caronline v van Heugten, Dr. prof., Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119620
- Sponsor's protocol ID
- BROCA-NIBS
- Acronym
- BROCA-NIBS
- Status last verified
- Nov 2023
- First submitted
- 26 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Outcome After Cardiac Arrest. Modifying Working Memory With Non-invasive Brain Stimulation - A Series of SCEDs
- ClinicalTrials.gov ID
- NCT06119620
- Acronym / sponsor ID
- BROCA-NIBS / BROCA-NIBS
- Conditions
- Cardiac Arrest, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 7 Nov 2023 (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.
The investigators want to investigate the effect of rTMS on working memory measured by the N-back task. This is a single case experimental design, ABAB.
Detailed description
Rationale: The survival rate of patients after cardiac arrest and resuscitation has increased considerably. A common consequence of cardiac arrest is ischemic-hypoxic brain damage leading to cognitive impairment. Currently, there is a lack of knowledge regarding effectiveness of treatments to improve outcomes of patients with cognitive impairment after a cardiac arrest.
Objective: The primary objective is to investigate the effects of rTMS (iTBS protocol) on working memory of people with memory impairments after a cardiac arrest in the past Study design: This will be a single blinded replicated randomized SCED withdrawal designs study.
Study population: Nine adults who had a cardiac arrest in the past will be participating in this study. They are recruited in the general population.
Intervention: If participants are suitable based on the screening. Participants are invited to the university of Maastricht. There they receive intermitted theta burst stimulation with a TMS coil for 3 minutes on the dorsolateral prefrontal cortex. Then they perform the N-back task for 8 to 12 minutes to estimate working-memory performance. Then they have a break (45 min). Then they receive 3 minutes of sham stimulation after which they have to perform the N-back task again for 8 - 12 minutes. This will be repeated (active stimulation - sham - active stimulation - sham).
Main study parameter: The main study outcomes are performance on the N-back task with regard to accuracy.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The participant has to come to the university twice. The screening session takes approximately 1-1,5 hour, the experimental session 3,5 hours. The participant could experience side effects of the rTMS, these include: headache, scalp discomfort, tingling or twitching of the facial muscles, and light-headedness. Serious side effects are very rare, but they may include: seizures. The N-back task can be experienced as tiring.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single case experimental design. All participants will receive both sham and active stimulation. The order of stimulation (sham, active, sham active OR active, sham, active, sham) will be randomised. Also the length of the N-back task is randomised between 8, 10, and 12 minutes).
| Arm | Type | Receives |
|---|---|---|
| ABAB | Other | Device: intermitted theta burst stimulationall participants will go through sham (control) and active (experimental) stimulation. So either sham - active - sham - active or active - sham - active - sham |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Had a cardiac arrest between 3 months and 5 years prior to the experiment session.
- Scores lower than the general population (corrected for age, education, and sex) on at least one of the cognitive tests ( SD < -1 on the Stroop, digit span, or TMT).
- Age 18 up to and including 75.
- Proficient in Dutch or English to understand the instructions for the N-back task.
- Has sufficient understanding to perform the N-back task.
Key exclusion criteria (5 listed)
- Has a pacemaker or ICD (implantable cardioverter-defibrillator)
- A history or a family member with a history of seizures / epilepsy (asked on the phone and checked on the first appointment).
- Metal implants in or near the head.
- Pregnancy
- Any other neurological disorder impending working memory performance besides the OHCA.
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 |
|---|---|---|
| intermitted theta burst stimulationAlso: rTMSParticipants receive intermitted theta burst stimulation for 3-4 minutes before completing the N-back task. | Device | ABAB |
Primary outcome
Accuracy on the N-back task
Time frame: 1 measurements every 2 minutes for 8 - 10 minutes after each N-back task (4 times in total)
Percentage of correct responses for every 2 N-back blocks
2 secondary outcomes
RT on the N-back task
Time frame: 1 measurements every 2 minutes for 8 - 10 minutes after each N-back task (4 times in total)
d' on the N-back task
Time frame: 1 measurements every 2 minutes for 8 - 10 minutes after each N-back task (4 times in total)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Caronline v van Heugten, Dr. prof. 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 intermitted theta burst stimulation in people with Cardiac Arrest and Cognitive Impairment, 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Nov 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pauline V van Gils, MSc (+31 (0)43 38 84095, c.vangils@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy on the N-back task (time frame: 1 measurements every 2 minutes for 8 - 10 minutes after each N-back task (4 times in total)). 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 7 Nov 2023.