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Behavioural Intervention
Sequence 1 for Obesity
N/A
Recruiting
Led By Dale Bond, PhD
Research Sponsored by Hartford Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be 18-60 years of age
Seeking to undergo primary (not revisional) bariatric surgery at HH
Must not have
Noise-induced hearing loss or tinnitus
History of any neurological disorder that would increase seizure risk from rTMS such as stroke, brain lesions, previous neurosurgery, any history of seizure or fainting episode of unknown cause, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than one month
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the rrv score will be obtained immediately before and immediately after the rtms and immediately before and after the sham tms
Awards & highlights
No Placebo-Only Group
Summary
This trial will explore if rTMS can reduce the reinforcing value of food and related reward processes in people who find food highly rewarding, compared to an alternative reinforcer.
Who is the study for?
This trial is for adults aged 18-60 who are planning to have bariatric surgery, can consent in English, and typically eat breakfast before 8 AM. They should not have cognitive impairments or ADHD, with an IQ of at least 80. Participants must also exhibit high levels of pleasure-driven eating and overeating susceptibility but meet safety standards for EEG and rTMS procedures.
What is being tested?
The study tests if transcranial magnetic stimulation (rTMS) can reduce the desire to eat for pleasure rather than hunger among preoperative bariatric patients. It involves two sessions: one with real rTMS and another with sham (fake) treatment, both targeting the brain's reward centers while measuring food reinforcement value against money.
What are the potential side effects?
While side effects are not detailed here, typical ones from rTMS may include headache, scalp discomfort at the site of stimulation, tingling or spasms in facial muscles, lightheadedness, or seizures (very rare).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 60 years old.
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I am planning to have my first weight loss surgery at HH.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have hearing loss or ringing in my ears due to loud noise.
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I have no history of neurological disorders or events that increase seizure risk.
Select...
I am not using any experimental drugs or medications that affect seizures.
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I am currently being treated for a heart condition or stroke.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the rrv score will be obtained immediately before and immediately after the rtms and immediately before and after the sham tms
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the rrv score will be obtained immediately before and immediately after the rtms and immediately before and after the sham tms
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in scores on the Relative-Reinforcing Value (RRV) of Food Questionnaire
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Sequence 2Experimental Treatment1 Intervention
Sham TMS followed by TMS
Group II: Sequence 1Experimental Treatment1 Intervention
TMS followed by sham TMS
Find a Location
Who is running the clinical trial?
Hartford HospitalLead Sponsor
138 Previous Clinical Trials
19,385 Total Patients Enrolled
7 Trials studying Obesity
621 Patients Enrolled for Obesity
Dale Bond, PhDPrincipal InvestigatorHartford HealthCare
1 Previous Clinical Trials
32 Total Patients Enrolled
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