Modifying Working Memory With Brain Stimulation

NCT06119620 | Unknown

• 1 other identifier: BROCA-NIBS
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Arrest; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• RT 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

  1 measurements every 2 minutes for 8 - 10 minutes after each N-back task (4 times in total)

Study Arms (1)

ABAB

OTHER

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

Interventions

intermitted theta burst stimulation DEVICE

Participants receive intermitted theta burst stimulation for 3-4 minutes before completing the N-back task.

Also known as: rTMS

ABAB

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University: lead

Study Sites (1)

Maastricht University

Maastricht, Limburg, Netherlands

RECRUITING

MeSH Terms

Conditions

Heart Arrest; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Caronline v van Heugten, Dr. prof.

  Maastricht University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pauline V van Gils, MSc

CONTACT

+31 (0)43 38 84095; c.vangils@maastrichtuniversity.nl

Caroline v van Heugten, Dr. prof.

CONTACT

+31 (0)43 388 4213; c.vanheugten@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The participant won't be told if they receive sham or active stimulation.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 7, 2023
• Study Start: November 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)