Back to resultsA Pilot Study of TMS Effects on Pain and Depression in Patients With Fibromyalgia (TMS)
Primary Purpose
Major Depression, Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active TMS
Sham TMS
Sponsored by
About this trial
This is an interventional treatment trial for Major Depression focused on measuring Major Depression, Fibromyalgia, TMS
Eligibility 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.
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active TMS
Sham TMS
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00523302
First Posted
August 30, 2007
Last Updated
June 12, 2018
Sponsor
Medical University of South Carolina
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1. Study Identification
Unique Protocol Identification Number
NCT00523302
Brief Title
A Pilot Study of TMS Effects on Pain and Depression in Patients With Fibromyalgia
Acronym
TMS
Official Title
A Pilot Study of Transcranial Magnetic Stimulation (TMS) Effects on Pain and Depression in Patients With Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2007 (Actual)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression, Fibromyalgia
Keywords
Major Depression, Fibromyalgia, TMS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active TMS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham TMS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Active TMS
Other Intervention Name(s)
Neotonus model 2100 xxx
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham TMS
Other Intervention Name(s)
Neotonus model 2100 xxx
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average Pain
Description
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.
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
Title
THE FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQ)-Modified
Description
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.
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
Title
THE HAMILTON DEPRESSION RATING SCALE (HRDS)
Description
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.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward B Short, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21764215
Citation
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.
Results Reference
result
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A Pilot Study of TMS Effects on Pain and Depression in Patients With Fibromyalgia
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