Clinical trial NCT02196025: Transcranial Magnetic Stimulation for Treatment of Insomnia
Official title: An Open Label Trial of Sequential Bifrontal Low Frequency Repetitive Transcranial Magnetic Stimulation (r-TMS) in the Treatment of Primary Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2014-07-21
Enrollment: 23
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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).

Eligibility 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 Diagnostic and Statistical Manual (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

Primary outcomes:
measure: Pittsburgh Sleep Quality Index ( PSQI)
timeFrame: three weeks
Secondary outcomes:
measure: Insomnia Severity Index ( ISI)
timeFrame: three weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF @ Shands
state: Florida
Study officials:
affiliation: University of Florida
name: Richard Holbert, MD
role: PRINCIPAL_INVESTIGATOR
References: