Fibromyalgia Clinical Trial
Official title:
A Pilot Study to Assess the Tolerability and Exploratory Efficacy of Vagus Nerve Stimulation (VNS) Using the VNS Therapy System in Patients With Refractory Fibromyalgia With and Without Major Depression
Fibromyalgia syndrome (FMS) is a long-term disorder that is characterized by widespread body pain and tender points in joints, muscles, tendons, and other soft tissues. Other symptoms associated with the disorder include fatigue and depression. The cause of FMS is unknown, and conventional treatments are often unsuccessful in adequately relieving pain. For people with severe, unrelenting pain, which is referred to as refractory FMS, opioid maintenance therapy may be an option, but it comes with the dangerous potential of addiction and is therefore avoided if possible. Vagus nerve stimulation (VNS), in which a nerve located in the neck receives electrical input, may be an option for providing pain relief. The purpose of this study is to determine the safety, tolerability, and effectiveness of VNS as a treatment for people with refractory FMS.
FMS affects about 5% of the general population and occurs most often in women between the
ages of 20 and 50 years old. Overall, more than 80% of FMS patients report that pain is the
primary symptom that limits their ability to work, about 30% of patients are disabled, and
about 45% collect Social Security Disability insurance. Conventional treatments, which
include pharmacological and behavioral interventions, fail to provide adequate pain relief
in more than half of FMS patients, strongly suggesting the need for improved treatment
options.
One such option is a treatment called vagus nerve stimulation (VNS), in which short bursts
of electrical energy are directed into the brain by way of the vagus nerve. The vagus nerve
is a cranial nerve that originates in the brainstem, travels through the neck, and then
continues down through the thorax and abdomen. The nerve acts as both a sensory and motor
nerve, and it can regulate several brain areas involved in pain and emotional processing.
With VNS, a small battery device is surgically implanted under the skin, usually under the
chest, and provides the necessary electrical energy for stimulation. Although VNS has been
FDA approved for some forms of epilepsy and depression, it has yet to receive FDA approval
for FMS. Also, it is unknown whether the safety and tolerability profile of an FMS patient
receiving VNS is the same as that of a patient with epilepsy or depression who is receiving
VNS. The purpose of this study is to determine the safety, tolerability, and effectiveness
of VNS as a treatment option for adults with refractory FMS.
Participants will be in this study for about 25 months. An initial screening period that may
last up to 6 weeks will include a medical history review, various examinations, and the use
of a wrist-mounted device called an Actiwatch to record pain severity and mood over seven
consecutive days. Eligible participants will then undergo surgical implantation of the VNS
system. This will be followed by a 2-week recovery period, then a 2-week period of gradually
increasing the electrical output of the VNS system, and finally a 12-week VNS treatment
period during which the electrical output level will remain constant, unless a participant
develops intolerable side effects. Study visits will occur weekly for the first month after
implantation and then every 2 weeks during the treatment period. During most study visits,
participants will undergo a clinical assessment, including evaluation of any side effects,
and they will complete written assessments on pain, mood, fatigue, and quality of life and
sleep. The VNS system will also be checked for safety and programmed appropriately. During
the Week 16 visit, some of the screening evaluations will be repeated. Also at Week 16,
which will mark the end of the treatment period, participants will have the option to
continue receiving treatment. All participants will have follow-up evaluations at Months 6,
9, 12, and 24. Participants who wish to retain the VNS implantation beyond the length of the
study will be referred to a qualified neurologist for follow-up care. For the other
participants, the VNS system will be turned off and surgically explanted.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05659862 -
Digitally Assisted Behavioral Physical Activity Intervention in Fibromyalgia
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT03042728 -
Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program
|
N/A | |
Recruiting |
NCT06097091 -
Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia
|
N/A | |
Recruiting |
NCT04554784 -
Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia
|
N/A | |
Completed |
NCT03300635 -
Metabolism, Muscle Function and Psychological Factors in Fibromyalgia
|
N/A | |
Recruiting |
NCT06166563 -
Exercise, Irritable Bowel Syndrome and Fibromyalgia
|
N/A | |
Completed |
NCT03166995 -
Postural Exercises in Women With Fibromyalgia
|
N/A | |
Completed |
NCT03227952 -
Sensory Stimulation in Fibromyalgia
|
N/A | |
Recruiting |
NCT06237595 -
Vagus Nerve Stimulation in Fibromyalgia
|
N/A | |
Completed |
NCT01888640 -
Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)
|
N/A | |
Completed |
NCT03641495 -
Pain Education and Therapeutic Exercise for Fibromyalgia
|
N/A | |
Recruiting |
NCT05581628 -
FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
|
||
Active, not recruiting |
NCT05128162 -
Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia
|
Phase 2 | |
Completed |
NCT04674878 -
Comparison of Muscle Energy Techniques and Breathing Exercises for Functional Improvement in Fibromyalgia
|
N/A | |
Active, not recruiting |
NCT04084795 -
Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia
|
N/A | |
Completed |
NCT03129906 -
Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients
|
N/A | |
Completed |
NCT05058911 -
Exposure-based Cognitive Behavior Therapy vs Traditional Cognitive Behavior Therapy for Fibromyalgia
|
N/A | |
Recruiting |
NCT04571528 -
Effectiveness of VIRTUAL FIBROWALK STUDY
|
N/A | |
Recruiting |
NCT04571853 -
New Educational Tool for FM
|
N/A |