Accelerated Transcranial Magnetic Stimulation (TMS) for Depression
ATMS
2 other identifiers
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 depression
Started Feb 2005
Longer than P75 for phase_1 depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 2, 2005
CompletedFirst Posted
Study publicly available on registry
November 4, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedSeptember 19, 2014
September 1, 2014
3.9 years
November 2, 2005
September 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hamilton Depression Scale
2-42 days
Study Arms (1)
Arm 1
OTHERInterventions
a device which produces intense magnetic fields in the brain and activates cerebral neurons
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, 30033, United States
Related 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.
PMID: 20734360RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2005
First Posted
November 4, 2005
Study Start
February 1, 2005
Primary Completion
January 1, 2009
Study Completion
June 1, 2009
Last Updated
September 19, 2014
Record last verified: 2014-09