Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:55 PM
Study NCT ID:
NCT06770556
Status:
RECRUITING
Last Update Posted:
2025-03-28
First Post:
2025-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transcranial Magnetic Stimulation (TMS) Effects Using Magnetoencephalography (MEG) Study
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
An Investigation of TMS Effects Using Magnetoencephalography (MEG) Among Individuals With and Without Heavy Alcohol Use
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TMS
Brief Summary:
Alcohol use disorder (AUD) is a complex chronic brain disease characterized by compulsive alcohol use, loss of control over drinking, and negative emotional states. Extensive research has identified the general neural circuitry underlying AUD. There is an exciting opportunity to intervene in AUD using neuromodulation. Transcranial magnetic stimulation (TMS) offers a non-invasive method to modulate brain activity, making it a promising tool for investigating, modulating, and potentially treating AUD. However, the precise effects of TMS on neural circuits involved in AUD and the mechanisms underlying these effects must first be understood. Magnetoencephalography (MEG) is a neuroimaging method that provides direct measurement of brain activity within neural circuits with high temporal resolution. Critically, MEG can measure brain activity in a wide range of frequencies that are consistent with those targeted by TMS. The goal of this proposal is therefore to collect preliminary and feasibility data to support a future NIH grant application that would use MEG to investigate TMS effects in individuals with AUD (iAUD).
Detailed Description:
This proposal uses a mixed, between-group, within-subject design. The study will investigate the acute effects of different TMS pulse sequences in participants without AUD (non-AUD), and compare active/sham iTBS across non-AUD and AUD. On each study day, participants will complete a pre-TMS baseline MEG scan (10 min resting state), followed by a TMS pulse sequence, then complete 3 more MEG scans (immediately post-TMS, 1 hour post-TMS, and 2 hours post-TMS). Each TMS pulse sequence will be administered on a separate day and will be matched by the number of pulses administered (1200 pulses) and the total duration of administration time (20 min). The sham condition will control for auditory and sensory side effects associated with TMS. TMS will be applied to the left DLPFC, identified by the EEG F3 coordinate. Participants will either complete 4 study visits (n = 5) and receive 1 Hz, 10 Hz, iTBS, and sham, each on a separate day; or participants will complete 2 study visits (n = 5) and receive iTBS and sham, each on a separate day. Participants will also receive a structural MRI scan in order to map the MEG outcome data onto their own anatomical brain image.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: