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Accelerated Transcranial Magnetic Stimulation (TMS) for Depression (ATMS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00248768
First Posted: November 4, 2005
Last Update Posted: September 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
The purpose of this study is to determinate if accelerated rTMS treatment over 1.5 days is effective for ameliorating depression in Parkinson's disease.

Condition Intervention Phase
Depression Device: Transcranial magnetic Stimulator Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Accelerated Transcranial Magnetic Stimulation for Depression

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Hamilton Depression Scale [ Time Frame: 2-42 days ]

Enrollment: 20
Study Start Date: February 2005
Study Completion Date: June 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1 Device: Transcranial magnetic Stimulator
a device which produces intense magnetic fields in the brain and activates cerebral neurons

Detailed Description:

Objective: The goal of this study is to investigate a new approach to administering repetitive transcranial magnetic stimulation (rTMS) in patients with refractory depression. (Please Note: The original requirement for comorbid Parkinson's disease has been dropped from this study).

Research Plan: This inpatient study will provide an initial test for the hypothesis that accelerated rTMS is an effective treatment for depression. Followup testing will help delineate the time course of response.

Methods: The rTMS treatment site over left dorsolateral prefrontal cortex will be 5.5cm anterior to the hand motor area. Treatments consisting of 1000 total pulses at 10 Hz and 100% motor threshold will be administered hourly for 1.5 days, totaling 15 sessions. A comprehensive test battery will be administered just before and after treatment, at 3 weeks, and at 6 weeks after treatment.

Clinical Relevance: We expect that accelerated rTMS treatments will lessen the degree of depression to the same extent as rTMS treatments of longer duration, but far more rapidly. A much shorter hospitalization would be more easily tolerated. In addition, reducing the duration of hospitalization substantially reduces burdens and costs to hospital, staff, and caregivers, while more rapidly enhancing function and quality of life.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-80 years.
  • Patients who meet DSM-IV criteria for Major Depressive Episode, severe, treatment resistant, with or without psychotic features.
  • Consent to treatment with rTMS.

Exclusion Criteria:

  • Patients with Delirium or Substance Dependence within the last 6 months. Patients will be screened initially with the Michigan Alcohol Screening Test (MAST) and Mini-Mental Status Examination and further evaluated if clinically indicated.
  • Patients with other significant central neurological disorders including increased intracranial pressure, brain mass, epileptic seizures, stroke, transient ischemic attack within two years, cerebral aneurysm, dementia, multiple sclerosis or other major CNS dysfunction.
  • Pregnant women.
  • Patients with cardiac pacemakers, other intracardiac lines, cochlear implants, aneurism clips, or other intracranial implants with the exception of dental fillings.
  • Patients with significant heart disease or with acute, unstable medical conditions that require stabilization (e.g., uncontrolled hypertension, bleeding) prior to treatment.
  • Patients who require continued treatment with antipsychotics including clozapine and risperidone, benzodiazepines, lithium or anticonvulsants. Patients will be allowed to continue on a stable dose of antidepressants and use zolpidem, since the latter is not felt to affect seizure threshold.
  • Patients who are unable to ambulate independently and complete the assessment protocol.
  Contacts and Locations
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): NCT00248768


Locations
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
VA Office of Research and Development
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00248768     History of Changes
Obsolete Identifiers: NCT00449371
Other Study ID Numbers: B3357-R
Emory IRB 601-2004 ( Other Identifier: Emory IRB )
First Submitted: November 2, 2005
First Posted: November 4, 2005
Last Update Posted: September 19, 2014
Last Verified: September 2014

Keywords provided by VA Office of Research and Development:
Depression
Parkinson Disease
Transcranial Magnetic Stimulation

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders