Modifying Working Memory With Brain Stimulation (BROCA-NIBS)

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment; Cardiac Arrest
• Intervention / Treatment: Device: intermitted theta burst stimulation

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 Type: Interventional
• Enrollment (Estimated): 9
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pauline V van Gils, MSc; Phone Number: +31 (0)43 38 84095; Email: c.vangils@maastrichtuniversity.nl
• Study Contact Backup: Name: Caroline v van Heugten, Dr. prof.; Phone Number: +31 (0)43 388 4213; Email: c.vanheugten@maastrichtuniversity.nl

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands
      • Recruiting
      • Maastricht University
      • Contact: Pauline van Gils, Drs.; Phone Number: 0031433884095; Email: c.vangils@maastrichtuniversity.nl
      • Contact: Caroline van Heugten, Prof. Dr.; Phone Number: +31-43-3884090; Email: caroline.vanheugten@maastrichtuniversity.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ABAB; all participants will go through sham (control) and active (experimental) stimulation. So either sham - active - sham - active or active - sham - active - sham	Device: intermitted theta burst stimulation; Participants receive intermitted theta burst stimulation for 3-4 minutes before completing the N-back task.; Other Names: rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy on the N-back task	Percentage of correct responses for every 2 N-back blocks	1 measurements every 2 minutes for 8 - 10 minutes after each N-back task (4 times in total)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RT on the N-back task	reaction time on the N-back task	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)	1 measurements every 2 minutes for 8 - 10 minutes after each N-back task (4 times in total)

Collaborators and Investigators

• Sponsor: Maastricht University
• Investigators: Principal Investigator: Caronline v van Heugten, Dr. prof., Maastricht University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: November 6, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: BROCA-NIBS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No