- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00523302
A Pilot Study of TMS Effects on Pain and Depression in Patients With Fibromyalgia (TMS)
A Pilot Study of Transcranial Magnetic Stimulation (TMS) Effects on Pain and Depression in Patients With Fibromyalgia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age 18-80,
- meet ACR criteria for FM for more than 6 months,
- may or may not have a diagnosis of major depressive disorder (not bipolar) past or present,
- Current major depressive episode must be without psychotic features
- Not be on medication known to increase risk of TMS-induced seizures
- No prescription medication changes in the previous 4 weeks with agreement not to change during the treatment course (2 weeks) and 2 weeks thereafter
- No history of epilepsy or stroke or recent head trauma (LOC > 5 minutes) within the past 6 months
- African Americans will be initially sought out for study, however the recruitment may extend to include Caucasian and Hispanic subjects to carry out the study.
Exclusion Criteria:
- Primary, current diagnosis of schizophrenia
- Other (non-mood disorder) psychosis
- Mental retardation
- Substance dependence or abuse within the past 6 months (except nicotine)
- Psychotic features in this episode, dementia, or delirium
- Contraindication to rTMS
- Increased intracranial pressure
- Brain surgery, or head trauma with loss of consciousness for > 15 minutes
- Implanted electronic device
- Metal in the head, or pregnant
- Has an active autoimmune, endocrine, viral, or vascular disorder affecting the brain or unstable cardiac disease
- Uncontrolled hypertension, or severe renal or liver insufficiency
- Unstable and active suicidal intent or plan
- History of attempt requiring medical hospitalization within in the past 6 months
- -currently an involuntary inpatient on a psychiatric ward.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Active TMS
Since cortical stimulation can be performed non-invasively by active Transcranial Magnetic Stimulation (TMS), Participants in the active TMS group, receive five 20 minute active TMS treatment sessions per week for two weeks.
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Active TMS uses the active TMS coil to stimulate the cortical area of interest.
Active TMS involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week= 20,000 pulses per week, x 2 weeks = 40,000 pulses.
Other Names:
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Sham Comparator: Sham TMS
To prevent unwanted cortical activation, Sham TMS will be employed in the Sham TMS group.
For the Sham TMS group, a specially designed sham TMS coil will be used for all sham conditions.
This sham TMS coil produces auditory signals identical to active TMS coils but is shielded so that actual stimulation does not occur.
This approach is currently the state-of-the-art approach to sham TMS procedures and is employed in high-quality clinical TMS trials.
Participants in the sham TMS group receive five 20 minute Sham TMS treatment sessions per week for two weeks.
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Sham TMS uses the same stimulation frequency as the Active TMS but uses the Sham TMS coil instead to prevent actual stimulation from occurring (chosen as a priori stimulation based on studies showing antidepressant and anti-nociceptive effects): 10 Hertz - Pulse train duration (on time) 5 seconds, Power (intensity) level 120% of stored motor threshold, Inter-train interval (off time) 10 seconds (15 second cycle time).
Additionally, stimulation-train duration and inter-stimulus intervals were determined such that they are in compliance with current published rTMS safety guidelines.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Average Pain
Time Frame: Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up
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To assess each participant's average Pain in the past 24 hours, The Brief Pain Inventory (BPI)-short form will be administered.
The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings.
Participants rate their average pain in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.
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Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up
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THE FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQ)-Modified
Time Frame: Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up
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To assess the impact of fibromyalgia on each participant's function, the FIQ-modified (2002) version will be administered before each study visit. The FIQ-modified (2002) version assesses the following symptoms; physical Impairment, well-being, pain, fatigue, rested, stiffness, anxiety, and depression within the past 24 hours. Each symptom scale ranges from 0 to 10. For example, 0=no pain and 10=extreme pain, 0=not fatigued and 10=extremely fatigued. The final score is the total score which ranges from 0 to 80. Higher scores indicate greater impact of fibromyalgia on functioning. |
Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up
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THE HAMILTON DEPRESSION RATING SCALE (HRDS)
Time Frame: Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up
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To assess each participant's level of depression, the HRDS will be administered.
The HRDS is a 17-item clinician-rated scale that is designed to evaluate depressed mood, vegetative and cognitive symptoms of depression, and comorbid anxiety symptoms.
Eight items are scored on a 5-point scale, ranging from 0-4, where 0=not present and 4=severe.
Nine items are scored from 0-2, where 0=None, 1=Mild, and 2=Severe.
The final, total score ranges from 0-52.
Scores in the range of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression, and scores over 24 are indicative of severe depression.
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Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up
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Collaborators and Investigators
Investigators
- Principal Investigator: Edward B Short, MD, Medical University of South Carolina
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HR#17365
- AR049459 (Other Grant/Funding Number: Multidisciplinary Clinical Research Center Grant P60)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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