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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00248768
First received: November 2, 2005
Last updated: March 14, 2012
Last verified: March 2012

November 2, 2005
March 14, 2012
February 2005
January 2009   (final data collection date for primary outcome measure)
Hamilton Depression Scale [ Time Frame: 2-42 days ] [ Designated as safety issue: Yes ]
Hamilton Depression ScoreUnified Parkinson’s Disease Rating Scale
Complete list of historical versions of study NCT00248768 on ClinicalTrials.gov Archive Site
Not Provided
Clinical Global ImpressionRepeatable Battery for Assessment of Neurological StatusBrief Visuospatial Memory Test
Not Provided
Not Provided
 
Accelerated Transcranial Magnetic Stimulation (TMS) for Depression
Accelerated Transcranial Magnetic Stimulation for Depression

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Depression
Device: Transcranial magnetic Stimulator
a device which produces intense magnetic fields in the brain and activates cerebral neurons
1
Intervention: Device: Transcranial magnetic Stimulator
Holtzheimer PE 3rd, McDonald WM, Mufti M, Kelley ME, Quinn S, Corso G, Epstein CM. Accelerated repetitive transcranial magnetic stimulation for treatment-resistant depression. Depress Anxiety. 2010 Oct;27(10):960-3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Pregnant women.
  4. Patients with cardiac pacemakers, other intracardiac lines, cochlear implants, aneurism clips, or other intracranial implants with the exception of dental fillings.
  5. Patients with significant heart disease or with acute, unstable medical conditions that require stabilization (e.g., uncontrolled hypertension, bleeding) prior to treatment.
  6. 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.
  7. Patients who are unable to ambulate independently and complete the assessment protocol.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00248768
B3357-R, Emory IRB 601-2004, GCRC 4403E
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Charles Epstein, MD Atlanta VA Medical and Rehab Center, Decatur
Department of Veterans Affairs
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP