N/A
N=20
A Pilot Study of TMS Effects on Pain and Depression in Patients With Fibromyalgia
Major Depression · Fibromyalgia
Bottom Line
View on ClinicalTrials.gov: NCT00523302 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Average Pain — 5.60; 5.43; 4.90; 5.49 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active TMS (Device); Sham TMS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Pain |
5.60; 5.43; 4.90; 5.49; 3.99; 5.07 | — |
| PRIMARY THE FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQ)-Modified |
58.79; 54.38; 55.03; 51.22; 42.07; 51.50 | — |
| PRIMARY THE HAMILTON DEPRESSION RATING SCALE (HRDS) |
21.80; 17.60; 17.30; 17.40; 16.10; 15.30 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00523302). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.