Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06271746
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-02-14
Brief Title:
Treatment of Fibromyalgia With the FibroNova Neuromodulation Device
Sponsor:
Theranica
Organization:
Theranica
Study Overview
Official Title:
A Prospective Randomized Double-blind Sham-controlled Clinical Study Assessing the Safety and Efficacy of FibroNova for the Treatment of Fibromyalgia
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Fibromyalgia FM is a chronic disorder that affects the musculoskeletal system causing widespread pain tenderness and fatigue It is estimated to affect 1-5 of the population The primary symptom of fibromyalgia is widespread pain throughout the body accompanied by tenderness and sensitivity to pressure
Pharmacological treatments include drugs such as antidepressants anticonvulsants and painkillers Another treatment option for fibromyalgia is the use of devices such as Quell Other non-pharmacological treatment options for fibromyalgia include cognitive-behavioral therapy CBT biofeedback and relaxation techniques
Remote Electrical Neuromodulation REN is a non-pharmacological technology that induces subthreshold non-painful neurostimulation signals that activate an endogenic pain-management system termed Conditioned Pain Modulation CPM to produce generalized pain relief in remote body areas Multiple studies have shown that REN is safe and effective for the acute treatment of migraine in adults and adolescents as well as migraine prevention
The current study examines the safety and efficacy of REN technology implemented via the FibroNova device for treating fibromyalgia pain and related symptoms
Pharmacological treatments include drugs such as antidepressants anticonvulsants and painkillers Another treatment option for fibromyalgia is the use of devices such as Quell Other non-pharmacological treatment options for fibromyalgia include cognitive-behavioral therapy CBT biofeedback and relaxation techniques
Remote Electrical Neuromodulation REN is a non-pharmacological technology that induces subthreshold non-painful neurostimulation signals that activate an endogenic pain-management system termed Conditioned Pain Modulation CPM to produce generalized pain relief in remote body areas Multiple studies have shown that REN is safe and effective for the acute treatment of migraine in adults and adolescents as well as migraine prevention
The current study examines the safety and efficacy of REN technology implemented via the FibroNova device for treating fibromyalgia pain and related symptoms
Detailed Description:
Background Fibromyalgia FM is a chronic disorder that affects the musculoskeletal system causing widespread pain tenderness and fatigue It is estimated to affect 1-5 of the population The primary symptom of fibromyalgia is widespread pain throughout the body accompanied by tenderness and sensitivity to pressure Secondary symptoms include fatigue sleep disturbances cognitive difficulties headaches depression and anxiety The exact cause of fibromyalgia is unknown but it is believed to involve a combination of neurobiological genetic and environmental factors
There is no cure for fibromyalgia and only a minority of fibromyalgia patients continue taking medications for more than a short period due to either lack of efficacy side effects or both Pharmacological treatments include drugs such as antidepressants anticonvulsants and painkillers and operate by modulating pain signals in the brain and nervous system Another treatment option for fibromyalgia is the use of devices such as the Quell device by Neurometrix 3 Other non-pharmacological treatment options for fibromyalgia include cognitive-behavioral therapy CBT biofeedback and relaxation techniques 2
Remote Electrical Neuromodulation REN is a non-pharmacological technology that induces subthreshold non-painful neurostimulation signals that activate an endogenic pain-management system termed Conditioned Pain Modulation CPM to produce generalized pain relief in remote body areas Multiple studies have shown that REN is safe and effective for the acute treatment of migraine in adults and adolescents as well as migraine prevention
The CPM system which is deficient in patients with migraine has been shown to be abnormal in fibromyalgia patients as well suggesting that fibromyalgia patients could potentially benefit from activating the CPM via REN The current study aims to examine the safety and efficacy of REN technology implemented via the FibroNova device for the treatment of fibromyalgia pain and related symptoms
The FibroNova device
The device is a wireless wearable battery-operated stimulation unit controlled by a smartphone software application Treatments with FibroNova are self-administered by the user The FibroNova device includes several main components
A pair of electrodes covered with hydrogel and a removeable protective film
An electronic circuitry and a battery contained in a plastic case
A software that includes firmware and a software application for mobile platforms
An armband to improve the adhesiveness and enable a discreet treatment
The study design A prospective randomized double-blind sham-controlled trial The ratio between treatment and control groups will be 11 stratified by prior use of prescribed medications for FM up to 2 vs 3 or more the following are considered as FM medications for the stratification Dulloxetine Pregabalin Milnacipran Amitriptyline
The study will consist of two main phases and a voluntary open-label extension phase
4-week baseline phase- in which participants will report their symptoms daily via an electronic app diary with no intervention
12-week intervention phase- in which eligible participants perform two treatments per day using FibroNovaidentical looking sham placebo device according to randomization and continue to report symptoms daily via the app
12-week open-label extension phase OLE- upon completion of the intervention phase eligible participants will be offered to participate in an additional voluntary 12-week period in which they will receive active treatment
There is no cure for fibromyalgia and only a minority of fibromyalgia patients continue taking medications for more than a short period due to either lack of efficacy side effects or both Pharmacological treatments include drugs such as antidepressants anticonvulsants and painkillers and operate by modulating pain signals in the brain and nervous system Another treatment option for fibromyalgia is the use of devices such as the Quell device by Neurometrix 3 Other non-pharmacological treatment options for fibromyalgia include cognitive-behavioral therapy CBT biofeedback and relaxation techniques 2
Remote Electrical Neuromodulation REN is a non-pharmacological technology that induces subthreshold non-painful neurostimulation signals that activate an endogenic pain-management system termed Conditioned Pain Modulation CPM to produce generalized pain relief in remote body areas Multiple studies have shown that REN is safe and effective for the acute treatment of migraine in adults and adolescents as well as migraine prevention
The CPM system which is deficient in patients with migraine has been shown to be abnormal in fibromyalgia patients as well suggesting that fibromyalgia patients could potentially benefit from activating the CPM via REN The current study aims to examine the safety and efficacy of REN technology implemented via the FibroNova device for the treatment of fibromyalgia pain and related symptoms
The FibroNova device
The device is a wireless wearable battery-operated stimulation unit controlled by a smartphone software application Treatments with FibroNova are self-administered by the user The FibroNova device includes several main components
A pair of electrodes covered with hydrogel and a removeable protective film
An electronic circuitry and a battery contained in a plastic case
A software that includes firmware and a software application for mobile platforms
An armband to improve the adhesiveness and enable a discreet treatment
The study design A prospective randomized double-blind sham-controlled trial The ratio between treatment and control groups will be 11 stratified by prior use of prescribed medications for FM up to 2 vs 3 or more the following are considered as FM medications for the stratification Dulloxetine Pregabalin Milnacipran Amitriptyline
The study will consist of two main phases and a voluntary open-label extension phase
4-week baseline phase- in which participants will report their symptoms daily via an electronic app diary with no intervention
12-week intervention phase- in which eligible participants perform two treatments per day using FibroNovaidentical looking sham placebo device according to randomization and continue to report symptoms daily via the app
12-week open-label extension phase OLE- upon completion of the intervention phase eligible participants will be offered to participate in an additional voluntary 12-week period in which they will receive active treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None