Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
72 participants
INTERVENTIONAL
2023-04-24
2028-06-30
Brief Summary
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Detailed Description
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The study will utilize a double-blinded randomized parallel design: adult inpatients with AN will receive either HF-rTMS or sham to the DLPFC. We will compare group changes in brain and behavior to test whether activity in the dorsal striatum underlies restrictive eating behavior in AN and quantify the effects of HF-rTMS to the DLPFC on restrictive eating behavior. Our use of individualized TMS targets will enable us to identify whether resting-state functional connectivity predicts neural or behavioral response to HF-rTMS.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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High-frequency repetitive transcranial magnetic stimulation (HF-rTMS)
Target: Region of right DLPFC with greatest resting-state functional connectivity to dorsal striatum (individualized functional target) Protocol: 10 pulses/sec, 4s trains, 120% MT, 3000 pulses/session
High-frequency repetitive transcranial magnetic stimulation (active rTMS)
HF-rTMS is applied with a figure-of-8 coil using the Magstim TMS System. Participants receive one administration of HF-rTMS, delivered to the region of the right dorsolateral prefrontal cortex (DLPFC) with greatest resting-state functional connectivity to the dorsal striatum (individualized per participant). HF-rTMS is delivered at a frequency of 10 Hz for approximately 37 minutes (3000 total pulses).
Sham repetitive transcranial magnetic stimulation (sham rTMS)
Target: Region of right DLPFC with greatest resting-state functional connectivity to dorsal striatum (individualized functional target) Protocol: same as HF-rTMS, with sham coil
Sham repetitive transcranial magnetic stimulation (sham rTMS)
Sham rTMS is applied with a figure-of-8 sham coil using the Magstim TMS System, which is identical to the active coil, replicates the sounds of HF-rTMS, and is designed to mimic sensations of HF-rTMS. Participants receive one administration of sham rTMS, delivered to the region of the right dorsolateral prefrontal cortex (DLPFC) with greatest resting-state functional connectivity to the dorsal striatum (individualized per participant). Sham rTMS is delivered for approximately 37 minutes (3000 total pulses).
Interventions
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High-frequency repetitive transcranial magnetic stimulation (active rTMS)
HF-rTMS is applied with a figure-of-8 coil using the Magstim TMS System. Participants receive one administration of HF-rTMS, delivered to the region of the right dorsolateral prefrontal cortex (DLPFC) with greatest resting-state functional connectivity to the dorsal striatum (individualized per participant). HF-rTMS is delivered at a frequency of 10 Hz for approximately 37 minutes (3000 total pulses).
Sham repetitive transcranial magnetic stimulation (sham rTMS)
Sham rTMS is applied with a figure-of-8 sham coil using the Magstim TMS System, which is identical to the active coil, replicates the sounds of HF-rTMS, and is designed to mimic sensations of HF-rTMS. Participants receive one administration of sham rTMS, delivered to the region of the right dorsolateral prefrontal cortex (DLPFC) with greatest resting-state functional connectivity to the dorsal striatum (individualized per participant). Sham rTMS is delivered for approximately 37 minutes (3000 total pulses).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18-30 years
* Female
* Right-handed
* Body Mass Index (BMI) ≥ 16.0
* Voluntarily admitted to inpatient eating disorders unit at NYSPI
* Competent to provide informed consent
* English-speaking
* Medically stable
Exclusion Criteria
* Current substance use disorder or other co- morbid psychiatric condition requiring specialized treatment (e.g., psychosis)
* Diagnosis of major medical or neurological problem or taking medication that significantly increases risk for seizure or affects interpretation of findings (e.g., unstable hypertension, seizure disorder)
* Food restrictions (e.g., allergies) which impact greater than 30% of food choice task's choice options
* Indwelling ferromagnetic metallic object (e.g., pacemaker, pump), non- removable metal jewelry, medicinal patch or recent metallic ink tattoo
* History of seizure
* Diagnosis of epilepsy, stroke, multiple sclerosis, traumatic brain injury, Alzheimer's and other neurodegenerative diseases, meningoencephalitis or intracerebral abscess, or parenchymal or leptomeningeal cancers
* Prior exposure to TMS
* Pregnancy
* Currently breast-feeding
* Significant claustrophobia
* Implanted devices or stimulators
* Hearing loss (e.g., currently undergoing treatment with ototoxic medications or those with cochlear implants)
18 Years
30 Years
FEMALE
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
National Eating Disorders Association
OTHER
Global Foundation for Eating Disorders
UNKNOWN
New York State Psychiatric Institute
OTHER
Responsible Party
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Alexandra F Muratore, PhD
Assistant Professor of Clinical Medical Psychology (in Psychiatry)
Principal Investigators
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Alexandra F Muratore, PhD
Role: PRINCIPAL_INVESTIGATOR
New York Sate Psychiatric Institute
Locations
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New York State Psychiatric Institute
New York, New York, United States
Countries
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Other Identifiers
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#8338
Identifier Type: -
Identifier Source: org_study_id
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