Transcranial Magnetic Stimulation for Treatment of Insomnia

NCT02196025 | Completed Results DMC FDA Device

• 1 other identifier: IRB201400335
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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).

Conditions

Insomnia

Keywords

Insomnia

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index ( PSQI)

  Change in Pittsburgh sleep quality index scores at the end of three weeks of stimulation with transcranial magnetic stimulation. Minimum Score = 0 (good sleep); Maximum Score = 30 (disrupted sleep)

  three weeks

Secondary Outcomes (1)

• Insomnia Severity Index ( ISI)

  three weeks

Study Arms (1)

Transcranial magnetic stimulation

EXPERIMENTAL

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

Interventions

Transcranial magnetic stimulation DEVICE

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.

Also known as: repetitive Transcranial magnetic stimulation, r-TMS, TMS

Transcranial magnetic stimulation

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred for evaluation and management of insomnia to our sleep disorders clinic will be offered enrollment in this study
• Patients must meet Diagnostic and Statistical Manual (DSM) IV criteria for Primary insomnia
• Aged 21-65 years to target relatively healthy adults

You may not qualify if:

• Patients with co-morbid depression
• Substance abuse in last two weeks
• No Psychotropic medication changes 2 weeks before start of TMS treatment and no changes during the 3 week treatment period
• 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
• Patients with ferromagnetic material in their head or within 30 cm of the coil will be excluded

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF @ Shands

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Robyn Nelson
• Organization: University of Florida

r.nelson@ufl.edu

3522945563

Study Officials

• Richard Holbert, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 21, 2014
• Study Start: May 1, 2015
• Primary Completion: July 21, 2021
• Study Completion: July 21, 2021
• Last Updated: August 6, 2024
• Results First Posted: August 6, 2024

Record last verified: 2024-07

Locations

US (1)