Accelerated Transcranial Magnetic Stimulation (TMS) for Depression

Depression Clinical Trial

— ATMS  

Official title:

Accelerated Transcranial Magnetic Stimulation for Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00248768
• Other study ID #: B3357-R
• Secondary ID: Emory IRB 601-20
• Status: Completed
• Phase: Phase 1
• First received: November 2, 2005
• Last updated: September 18, 2014
• Start date: February 2005
• Est. completion date: June 2009

Study information

• Verified date: September 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Other known NCT identifiers

• NCT00449371

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• Transcranial magnetic Stimulator
a device which produces intense magnetic fields in the brain and activates cerebral neurons

Locations

Country	Name	City	State
United States	Atlanta VA Medical and Rehab Center, Decatur	Decatur	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. doi: 10.1002/da.20731. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Scale		2-42 days	Yes