Health TrialsbyHealthPanel

Targeting Specific Brain Networks to Treat Specific Symptoms in Depression

ConditionMajor Depressive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18-65 years of age

Capacity to provide informed consent form to participate in the study

18-65 years of age

Capacity to provide informed consent form to participate in the study

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Intermittent Theta Burst Stimulation (iTBS)

    Device

    iTBS is a form of non-invasive brain stimulation used to treat depression. It works on the principles of electromagnetic induction.

Treatment groups

80 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: DLPFC Salience network targetExperimental treatment 1 intervention
Group B: DLPFC Control network targetExperimental treatment 1 intervention
Group C: DLPFC Default network A targetExperimental treatment 1 intervention
Group D: dmPFC Default network B targetExperimental treatment 1 intervention
Group E: vmPFC limbic-reward network targetExperimental treatment 1 intervention
Group F: SHAM stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Resting-state functional connectivity (FC)

Changes in connectivity within and between brain networks

Time frame
1 hour
2

Blood oxygenation level dependent (BOLD) activation

Changes in activation resulting from performing a specific functional MRI (fMRI) task

Time frame
1 hour
3

Applied Cognition-General Concerns scale

Subjects rate how statements about cognition and attention apply to them, e.g., "Thinking is foggy." Score range is 8-40, with higher scores indicating lesser cognitive concerns.

Time frame
10 minutes
4

Profile of Mood States Tension subscale

Subjects are asked to rate how much certain adjectives about their mood apply to them at that moment, e.g., "tense", "nervous", "shaky." Score range: 0-28, higher scores indicating more tension.

Time frame
5 minutes

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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