MedDataX Logo

Evaluation of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Mood Disorders

NCT ID: NCT00001545

Last Updated: 2006-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-05-31

Study Completion Date

2006-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is designed to evaluate repetitive transcranial magnetic stimulation (rTMS) as a potential treatment for depression. In rTMS, a rapidly changing magnetic field passes through your scalp and skull and generates a small electrical pulses in your brain. rTMS at lower intensities has helped some people with depression but we do not know what the results will be in your case using higher intensities, or whether you will be randomized to 3 weeks of high frequency (20 cycles er second), low frequency (1 cycle per second), or inactive (sham)rTMS. You will be assigned to receive one of these types of rTMS over the left front art of your brain five times per week for the three weeks. Each rTMS treatment session should take between 20-30 minutes of actual stimulation, but weekly ratings, memory testing, and blood sampling may require several hours per week. We will also ask you to have brain imaging procedures to see if these will predict response to high vs. low frequency rTMS. If you are randomized to the 3 weeks of sham rTMS, you will have the opportunity to receive one of the active stimulation frequencies for an additional 3 weeks. Responders to any phase will be offered an additional month of rTMS prior to study termination and recommendations of alternative treatments.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Repetitive transcranial magnetic stimulation (rTMS) is a new technique for activating the brain noninvasively through the scalp and skull. It has proven effective in producing localized effects on brain function and has opened many areas of human brain function to direct investigation. Preliminary data also suggest potential therapeutic applications in neuropsychiatric illness. We plan to further investigate the possible therapeutic use of rTMS in depression under conditions of high frequency (20 Hz), low (1Hz) frequency, and sham and to also examine possible cognitive or endocrine effects. Among the priorities of this protocol will be to further evaluate the risks of the technique.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bipolar Disorder Mood Disorder Unipolar Depression

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Affective Disorders Repetitive Transcranial Magnetic Stimulation Mania Bipolar Disorder Depression Unipolar Disorder Unipolar Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Magstim Super Rapid Magnetic Stimulator

Intervention Type DEVICE

Cadwell MES-10

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

All patients will receive a psychiatric and physical examination by a qualified physician.

Patients will be from 18 to 90 years of age and must give informed consent.

Unipolar patients must be medication free to participate. Patients with bipolar disorder depression may be medication-free or on any combination (including monotherapy) of lithium, carbamazepine, and valproate. Inpatient monitoring will be provided when medically indicated.

Exclusion Criteria

Reasons for exclusion will be the presence of cardiac pacemakers, medication pumps, cochlear implants or metal objects in the head or eyes that could be dangerous if heated or moved by the magnetic pulses.

General contraindications to rTMS or a current diagnosis of alcohol or substance abuse.

Subjects having serious medical illnesses or meeting current psychoactive substance dependence will be excluded from entry.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role lead

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Institute of Mental Health (NIMH)

Bethesda, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Speer AM, Kimbrell TA, Wassermann EM, D Repella J, Willis MW, Herscovitch P, Post RM. Opposite effects of high and low frequency rTMS on regional brain activity in depressed patients. Biol Psychiatry. 2000 Dec 15;48(12):1133-41. doi: 10.1016/s0006-3223(00)01065-9.

Reference Type BACKGROUND
PMID: 11137053 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

96-M-0086

Identifier Type: -

Identifier Source: secondary_id

960086

Identifier Type: -

Identifier Source: org_study_id