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

NCT00523302 | Completed Results DMC FDA Device

• 2 other identifiers: HR#17365AR049459
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression; Fibromyalgia

Keywords

Major Depression; Fibromyalgia; TMS

Outcome Measures

Primary Outcomes (3)

• Average Pain

  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.

  Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up

• THE FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQ)-Modified

  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

• THE HAMILTON DEPRESSION RATING SCALE (HRDS)

  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.

  Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up

Study Arms (2)

Active TMS

ACTIVE COMPARATOR

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

Sham TMS

SHAM COMPARATOR

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

Interventions

Active TMS DEVICE

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.

Also known as: Neotonus model 2100 xxx

Active TMS

Sham TMS DEVICE

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.

Also known as: Neotonus model 2100 xxx

Sham TMS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• Short BE, Borckardt JJ, Anderson BS, Frohman H, Beam W, Reeves ST, George MS. Ten sessions of adjunctive left prefrontal rTMS significantly reduces fibromyalgia pain: a randomized, controlled pilot study. Pain. 2011 Nov;152(11):2477-2484. doi: 10.1016/j.pain.2011.05.033. Epub 2011 Jul 20.

  PMID: 21764215 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major; Fibromyalgia

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Edward B. Short
• Organization: Medical University of South Carolina

shortb@musc.edu

8437923295

Study Officials

• Edward B Short, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2007
• First Posted: August 31, 2007
• Study Start: July 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: July 11, 2018
• Results First Posted: July 11, 2018

Record last verified: 2018-05

Locations

US (1)