Targeting Specific Brain Networks to Treat Specific Symptoms in Depression
Recruiting · NCT05523817 · Interventional (participants receive a specific treatment) · Lead sponsor: Massachusetts General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Intermittent Theta Burst Stimulation (iTBS)
What this trial is about
Repetitive transcranial magnetic stimulation (rTMS) is a way of non-invasively stimulating specific brain networks and is an established treatment for Major Depressive Disorder (MDD). This proposal will reveal network mechanisms of the therapeutic effects of rTMS by investigating how stimulating each network specifically changes network connectivity and behavior. This will be done in a highly individualized manner in depressed and healthy patients, leading to more effective and more individualized treatments for depression.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- for healthy participants:
- 18-65 years of age
- Capacity to provide informed consent form to participate in the study
- Inclusion Criteria for participants with Major Depressive Disorder (MDD):
- 18-65 years of age
- Capacity to provide informed consent form to participate in the study
- Currently in a major depressive episode. Comorbid anxiety disorders and personality disorders will be allowed provided that MDD is the primary diagnosis.
Exclusion criteria
- for all participants:
- Meeting criteria, in the past or currently, for bipolar affective disorder, hypomania or mania.
- Meeting criteria, in the past or currently, for a primary psychotic disorder (e.g., schizophrenia).
- Neurological conditions with known structural brain lesions, e.g., intracranial masses, multiple sclerosis.
- Any personal history of seizures or a family history of epilepsy in a first-degree relative.
- Metal in the body that is ferromagnetic or metallic injury to the eyes.
- Implanted pacemakers, medication pumps, vagal stimulators, deep brain stimulators, or ventriculoperitoneal shunts, etc.
- Substance abuse or dependence that is current and active within the last six months, as indicated by self-report (e.g., heroin, cocaine, methamphetamines).
- Inability to meet the safety criteria for MRI scanning for any other reason.
- Severe or unstable medical illness.
- Currently pregnant, as assessed with urine pregnancy test in women of childbearing age.
Where it is running
1 location listed across 1 US state.
- Massachusetts General Hospital - Boston, Massachusetts, United States