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Trial record 50 of 280 for:    impact | "Fibromyalgia"

A Pilot Study of TMS Effects on Pain and Depression in Patients With Fibromyalgia (TMS)

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ClinicalTrials.gov Identifier: NCT00523302
Recruitment Status : Completed
First Posted : August 31, 2007
Results First Posted : July 11, 2018
Last Update Posted : July 11, 2018
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:
In this pilot study, the PI proposes to include 20 African American participants with Fibromyalgia to explore the effect of r TMS on pain and depressive symptoms.

Condition or disease Intervention/treatment Phase
Major Depression Fibromyalgia Device: Active TMS Device: Sham TMS Not Applicable

Detailed Description:
In this pilot study, the PI proposes to include 20 African American participants with Fibromyalgia to explore the effect of r TMS on pain and depressive symptoms. The focus on African Americans is due to the mandate from the funding source (internal), as well as possible higher prevalence of FM in AA women. If recruitment is slow, the PI proposes to open up the study to other groups. Twenty subjects will be randomized to either sham or active TMS condition. Inclusion/exclusion criteria are well thought out and seem appropriate. mTreatments will be administered at IOP 5 times/wk with each session lasting 20 minutes. Pain intensity and unpleasantness will be measured pre and post each TMS session using three different pain evaluation paradigms. GCRC resource is mainly requested for two blood draws pre and post first TMS session. The blood samples will be used to measure inflammatory cytokines IL-1, IL-6, AND IL-8. The main aim is to ascertain feasibility of the study and secondary aim is to gather information on variability in response for power analysis for future larger study. The introduction and rationale (including pain evaluation, and methods relating to TMS) are clearly presented. Use of GCRC resources seem appropriate.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study of Transcranial Magnetic Stimulation (TMS) Effects on Pain and Depression in Patients With Fibromyalgia
Actual Study Start Date : July 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
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.
Device: Active TMS
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 Name: Neotonus model 2100 xxx

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.
Device: Sham TMS
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 Name: Neotonus model 2100 xxx




Primary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]

    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.


  3. 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 ]
    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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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT00523302


Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Edward B Short, MD Medical University of South Carolina

Additional Information:
Publications of Results:
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00523302     History of Changes
Other Study ID Numbers: HR#17365
AR049459 ( Other Grant/Funding Number: Multidisciplinary Clinical Research Center Grant P60 )
First Posted: August 31, 2007    Key Record Dates
Results First Posted: July 11, 2018
Last Update Posted: July 11, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Medical University of South Carolina:
Major Depression
Fibromyalgia
TMS

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases