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Brain Stimulation
Transcranial magnetic stimulation for Insomnia (TMSI Trial)
N/A
Waitlist Available
Led By Richard Holbert, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients referred for evaluation and management of insomnia to our sleep disorders clinic will be offered enrollment in this study
Patients must meet DSM IV criteria for Primary insomnia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three weeks
Awards & highlights
TMSI Trial Summary
This trial will investigate whether transcranial magnetic stimulation (TMS) can help treat patients with primary insomnia who have not responded to other treatments. TMS is a non-invasive brain stimulation technique that has been previously approved to treat depression.
Eligible Conditions
- Insomnia
TMSI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTMSI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ three weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pittsburgh Sleep quality index ( PSQI)
Secondary outcome measures
Insomnia severity index ( ISI)
TMSI Trial Design
1Treatment groups
Experimental Treatment
Group I: Transcranial magnetic stimulationExperimental Treatment1 Intervention
Patients will receive sequential bilateral bifrontal low frequency TMS stimulation daily on weekdays for three weeks. In addition, a Pittsburgh Sleep Quality Index (PSQI), Insomnia severity rating index, Montgomery Asberg Depression Rating Scale, and a sleep diary will be kept.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial magnetic stimulation
2015
Completed Phase 4
~480
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,336 Previous Clinical Trials
715,206 Total Patients Enrolled
4 Trials studying Insomnia
310 Patients Enrolled for Insomnia
Richard Holbert, MDPrincipal InvestigatorUniversity of Florida
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
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