T-mult: Exploring the Impact of TMS Induced Virtual Lesions on the Multimodal Brain Network and Cognition

Not Applicable

Recruiting

• Conditions: Healthy Cognition
• Interventions: Device: repetitive transcranial magnetic stimulation (rTMS)

• Registration Number: NCT05542641
• Lead Sponsor: Amsterdam UMC, location VUmc

Brief Summary

T-mult is an experimental study using low-frequency (1Hz) single-sesson rTMS to the DLPFC (versus sham rTMS) to explore the effect of virtual lesions on the brain network and cognition in 100 healthy adults (20-65 years old).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-12
• Study First Posted: 2022-09-15
• Status Verified: 2023-04
• Study Start: 2023-04-25
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-28
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age between 20 and 65 years old
• Native Dutch speaker
• Able to provide written informed consent

Exclusion Criteria

• History of diagnosed neurological or psychiatric disease (including traumatic head injury)
• Current and regular use of centrally acting drugs (recreational or prescribed, including analgesics), including the use of alcohol ~8 hours prior to an appointment
• Presence of any contraindications for MRI, MEG, or TMS (including resting motor threshold >75% of maximum stimulator output or no useful motor-evoked potential elicitable)
• Previous rTMS treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
real rTMS	repetitive transcranial magnetic stimulation (rTMS)	verum rTMS to the DLPFC, 1500 1Hz pulses at 120% RMT, 25 minutes total
sham rTMS	repetitive transcranial magnetic stimulation (rTMS)	sham rTMS to the DLPFC, 1500 1Hz pulses at 120% RMT, 25 minutes total

Primary Outcome Measures

Name	Time	Method
Cognitive change	baseline versus directly post-intervention (max. 8 weeks after baseline)	Change in performance on a neuropsychological test measuring cognitive functioning in the domain of executive functioning

Secondary Outcome Measures

Name	Time	Method
Brain network change	baseline versus directly post-intervention (max. 8 weeks after baseline)	Change in brain network organization as characterised by multimodal neuroimaging

Trial Locations

Locations (1)

VU University Medical Centers, location VUmc; 🇳🇱 Amsterdam, Netherlands