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BROCA-NIBS: Modifying Working Memory With Brain Stimulation

Sponsor
Maastricht University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06119620
Collaborator
(none)
9
Enrollment
1
Location
1
Arm
11
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: intermitted theta burst stimulation
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
9 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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).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)
Masking Description:
The participant won't be told if they receive sham or active stimulation.
Primary Purpose:
Basic Science
Official Title:
Brain Outcome After Cardiac Arrest. Modifying Working Memory With Non-invasive Brain Stimulation - A Series of SCEDs
Actual Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Accuracy on the N-back task [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

    Secondary Outcome Measures

    1. RT on the N-back task [1 measurements every 2 minutes for 8 - 10 minutes after each N-back task (4 times in total)]

      reaction time on the N-back task

    2. d' on the N-back task [1 measurements every 2 minutes for 8 - 10 minutes after each N-back task (4 times in total)]

      d' = z(False alarms) - z(Hits)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maastricht University Maastricht Limburg Netherlands

    Sponsors and Collaborators

    • Maastricht University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maastricht University
    ClinicalTrials.gov Identifier:
    NCT06119620
    Other Study ID Numbers:
    • BROCA-NIBS
    First Posted:
    Nov 7, 2023
    Last Update Posted:
    Nov 7, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Heart Arrest

    Study Results

    No Results Posted as of Nov 7, 2023