Completed

rTMS Treatment for Mood Disorders: High and Low Frequency Stimulation

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Magstim Super Rapid Magnetic Stimulator

+ Cadwell MES-10

Device
Who is being recruted

Bipolar and Related Disorders+11

+ Behavior

+ Mental Disorders

From 18 to 90 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 1996
See protocol details

Summary

Principal SponsorNational Institute of Mental Health (NIMH)
Last updated: July 13, 2006
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 1996

Actual date on which the first participant was enrolled.

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.

NCT00001545
Principal SponsorNational Institute of Mental Health (NIMH)
Last updated: July 13, 2006
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

91 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bipolar and Related DisordersBehaviorMental DisordersBehavioral SymptomsNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsManiaBipolar DisorderDepressionDepressive DisorderMood Disorders

Criteria

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institute of Mental Health (NIMH)

Bethesda, United StatesOpen National Institute of Mental Health (NIMH) in Google Maps
CompletedOne Study Center