Decoding and Modulating Affective Brain States
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Pennsylvania
About this trial
The research study is being conducted to study brain patterns of negative emotion and develop personalized brain stimulation protocols to disrupt these patterns with transcranial magnetic stimulation (TMS). First, the investigators will use functional Magnetic Resonance Imaging (fMRI) data to generate a negative affect map for each participant. Then, the investigators will apply a variety of repetitive transcranial magnetic stimulation (rTMS) sequences while the participant is inside the MRI scanner to determine the optimal and least optimal rTMS frequencies at changing negative affect brain states. Finally, these two frequencies will be tested over two 3-day rTMS neuromodulation sessions to assess whether they can reduce negative emotions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-65 years old
Patient Health Questionnaire (PHQ-9 score) = or > than 10
Comprehension of instructions in the English language.
Capacity to provide informed consent and follow study procedures.
Disqualifiers
Diagnosis of bipolar disorder (as PI discretion), schizophrenia or other psychotic disorder
Recent use of psychoactive medications or substances as determined by investigators
History of neurological disorder or traumatic brain injury (other than mild)
Unable to have an MRI scan, or current or prior medical condition that could interfere with the collection or interpretation of MRI data
Trial design
Design model
Crossover
Treatments tested in this trial
Transcranial Magnetic Stimulation
DeviceTranscranial Magnetic Stimulation (TMS) is a non-invasive form of brain stimulation. TMS can influence activity in various brain regions, and it allows researchers to test or modify brain circuit communication. The MagPro X100\* magnetic stimulator and Cool-B65 Butterfly Coil are FDA-approved for rTMS treatments of depression.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Neuromodulation using the optimal rTMS stimulation frequencyExperimental treatment 1 intervention
Group B: Neuromodulation using the least optimal rTMS stimulation frequencyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in ruminative response scale (RRS) score after using the optimal rTMS stimulation frequency vs the least optimal rTMS stimulation frequency
By comparing the RRS score change pre/post rTMS of both neuromodulation sessions (Visits 4-6/7-9) the investigators will determine whether the optimal rTMS stimulation frequency is more effective at improving clinical outcomes.
Time frame
Up to 4 weeksSponsors and contacts
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Source ClinicalTrials.gov