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Trial record 4 of 1361 for:    transcranial magnetic stimulation

Transcranial Magnetic Stimulation for Treatment of Insomnia (TMSI)

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ClinicalTrials.gov Identifier: NCT02196025
Recruitment Status : Recruiting
First Posted : July 21, 2014
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation technique that has been approved as a treatment of depression in patients that have not responded to a trial of one antidepressant medication. The investigators hypothesize that low frequency TMS exerts inhibitory effect on hyper excitable cortical state in patients with chronic insomnia and therefore is therapeutic. The investigators want to compare the change in insomnia scores between baseline and end of treatment in an open label trial with bifrontal low frequency TMS stimulation in 20 patients with primary insomnia using daily stimulation of 3 weeks (15 week days).

Condition or disease Intervention/treatment Phase
Insomnia Device: Transcranial magnetic stimulation Not Applicable

Detailed Description:

Insomnia is a common clinical problem that affects about 25 million people in the US. Insomnia exacts health and economic consequences well beyond inadequate and non-restorative sleep. It increases healthcare costs, causes or adds to medical and psychiatric comorbidities, cognitive impairments, accidents, absenteeism and reduced quality of life. Treatment of insomnia is difficult and usually needs a multimodal approach incorporating various cognitive and behavioral approaches in addition to medication treatment. TMS and other neurophysiological studies have shown presence of a diffuse cortical hyper-arousal in patients with chronic insomnia. High frequency TMS (>1 Hz) has been shown to be activating whereas low frequency TMS (<1Hz) has been shown to be inhibitory in clinical and neurophysiological studies. TMS has been approved as a treatment of depression in patients who have not responded to a trial of at least one antidepressant medication. The goal of this study is to translate the knowledge learned from neurophysiological studies of insomnia to the clinical treatment of insomnia using TMS as the primary modality.

Aim: Compare the change in insomnia scores between baseline and end of treatment with bifrontal low frequency TMS stimulation in 20 patients with primary insomnia using daily stimulation of 3 weeks (15 week days).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Trial of Sequential Bifrontal Low Frequency Repetitive Transcranial Magnetic Stimulation (r-TMS) in the Treatment of Primary Insomnia
Study Start Date : May 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Experimental: Transcranial magnetic stimulation
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.
Device: Transcranial magnetic stimulation
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.
Other Names:
  • repetitive Transcranial magnetic stimulation
  • r-TMS
  • TMS




Primary Outcome Measures :
  1. Pittsburgh Sleep quality index ( PSQI) [ Time Frame: three weeks ]
    Change in Pittsburgh sleep quality index scores at the ned of three weeks stimulation with transcranial magnetic stimulation. Minimum Score = 0 (good sleep); Maximum Score = 30 (disrupted sleep)


Secondary Outcome Measures :
  1. Insomnia severity index ( ISI) [ Time Frame: three weeks ]
    Change in insomnia severity index scores at the ned of three weeks stimulation with transcranial magnetic stimulation. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients referred for evaluation and management of insomnia to our sleep disorders clinic will be offered enrollment in this study
  2. Patients must meet DSM IV criteria for Primary insomnia
  3. Aged 21-65 years to target relatively healthy adults

Exclusion Criteria:

  1. Patients with co-morbid depression
  2. Substance abuse in last two weeks
  3. No Psychotropic medication changes 2 weeks before start of TMS treatment and no changes during the 3 week treatment period
  4. Patients with a major medical or psychiatric disorder that may be causing or contributing to insomnia: bipolar disorder, psychosis, anxiety disorders, dementia, seizure disorder and chronic pain
  5. Patients with ferromagnetic material in their head or within 30 cm of the coil will be excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02196025


Contacts
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Contact: Dana Mason 352-273-8540 dmason@ufl.edu

Locations
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United States, Florida
UF @ Shands Recruiting
Gainesville, Florida, United States, 32610
Principal Investigator: Richard Holbert, MD         
Sub-Investigator: Khurshid Khurshid, MD         
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Richard Holbert, MD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02196025     History of Changes
Other Study ID Numbers: IRB201400335
First Posted: July 21, 2014    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Florida:
Insomnia

Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders