Patients with Cluster Headache (CH) will be included. They will have a Holter electrocardiogram during 7 days.

Cluster Headache

Holter electrocardiogram will be carried during 7 days to measure heart's electrical activity continuously.

Holter electrocardiogram

CHU Saint-Etienne

Variability of the Autonomic Nervous System (ANS) During Cluster Headache (CH).

AVASNA : Variability of the Autonomic Nervous System (ANS) During Cluster Headache (CH).

Comparison of the Low Frequency/High Frequency (LF/HF) ratio at the onset of the first night seizure during the basal period, pre-seizure, seizure and after the seizure.

Comparison of the Low Frequency/High Frequency (LF/HF) ratio at the onset of the first daytime seizure during the basal period, pre-seizure, seizure and after the seizure.

Comparison of measure of Low Frequency during daytime and night seizure.

Comparison of measure of High Frequency (HF) during daytime and night seizure.

Correlation between Heart Rate Variability (HRV), changes in the Low Frequency/High Frequency (LF/HF) ratio, the Low Frequency (LF) and the High Frequency (HF), and the intensity of pain measured on the Visual Analog Scale (VAS).

Centre Hospitalier Universitaire de Saint Etienne

Subjects will be administered study treatment with the nVNS device 3 times per day (prophylaxis) and also as needed for acute respiratory symptoms.

Will receive standard of care therapies to treat CoViD-19 infection and symptoms

COVID

Corona Virus Infection

Respiratory Failure

Respiratory Distress Syndrome, Adult

ARDS, Human

SARS (Severe Acute Respiratory Syndrome)

Administer gammaCore® Sapphire daily, prophylactically, for three treatments (morning, mid-day and night, one hour before bed), each treatment consisting of two 2-minute doses/stimulations, one on each side of the neck. This would be a total of 6 treatments (2 doses x 3 times per day) of stimulation.
For acute respiratory distress or shortness of breath (SOB), administer one treatment consisting of two 2-minute stimulations, on the neck. If respiratory distress or shortness of breath persists 20 minutes after the start of the first treatment, administer a second treatment.

gammaCore® Sapphire (non-invasive vagus nerve stimulator)

Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms

Standard of care therapies

AHN Allegheny General Hospital

Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms

A Prospective, Randomized, Controlled Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms (SAVIORII)

measure the change (in hours) between the control group and treatment group

measure the changes in the serum/plasma concentrations of TH1 and TH2-type cytokines

compare the difference in oxygen requirements (liters/min) between the control group and active group for patients admitted to the hospital for CoViD-19.

measure the change (in hours) to death between control group and treatment group

measure the change (in hours) to time of mechanical ventilation between control group and treatment group

Tariq Cheema

Associate Division Director, AHN Pulmonary, Critical Care and Sleep Medicine

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

ElectroCore INC

During the trial implant of Senza™, High Frequency Spinal Cord Stimulator for Refractory Chronic Migraine, the 2 leads will be positioned to cover the C2-C3 cervical levels.
Over the following 2 weeks, the investigator will optimize therapy delivery by identifying the stimulation settings providing maximal headache pain relief.
The subject will be asked to attend the clinic at the end of the trial period. Together with his/her physician, the subject will discuss his/her experience over the past 2 weeks (satisfaction with the therapy), and decide whether or not move forward with a Nevro Senza IPG.
The Nevro Senza IPG will be implanted in the buttock or abdomen area as outlined in the Physician's Manual. Fluoroscopy and impedance measurements may be used during the procedure to confirm lead placement and location.
Before hospital discharge, the IPG will be programmed with the optimal settings identified during the trial phase.

Refractory Chronic Migraine

Senza™, High Frequency Spinal Cord Stimulator for Refractory Chronic Migraine

Sant'Andrea Hospital

A Feasibility Clinical Trial to Evaluate High Frequency Spinal Cord Stimulation for the Treatment of Patients With Chronic Migraine

Change of frequency in headache days from baseline

Change of frequency in migraine days from baseline

Change in frequency of moderate/severe headache days from baseline

Change in headache pain Visual Analog Scale (VAS) score from baseline

Change in Migraine Disability Assessment (MIDAS) Score from baseline

Change in frequency of triptans intake from baseline

Patient Global Impression of Change (PGIC)

Change in the number of sleep disturbances per night from baseline

Incidence of device-related adverse events

Paolo Martelletti

Professor, Internal Medicine

University of Roma La Sapienza

Guy's and St Thomas' NHS Foundation Trust

King's College Hospital NHS Trust

open label adjunctive add on of verapamil to existing medications. dosing begins at 1 mg/kg/d and increases weekly to target of 4 mg/kg/d in divided doses (three times/day)

Dravet Syndrome

Verapamil will be prepared as a solution. A 50mg/ml oral suspension may be made with immediate release tablets and either a 1:1 mixture of Ora-Sweet and Ora-Plus or a 1:1 mixture of Ora-Sweet SF and Ora-Plus will be used.
Children will start on a 4 weeks titration period:
Week 1: 1mg/kg/day divided BID Week 2: 2mg/kg/day divided BID or TID Week 3: 3mg/kg/day divided BID or TID Week 4: 4mg/kg/day divided TID
In event of adverse events, and in consultation with the family and treating physician, the dosage may be decreased to 2mg/kg/day and remain at that dose for the remainder of the study.

Verapamil

Children's Memorial Hospital

Mayo Clinic

Gillette Children's Specialty Healthcare

Mary Hitchcock Memorial Hospital

Verapamil as Therapy for Children and Young Adults With Dravet Syndrome

Verapamil as Adjunctive Seizure Therapy for Children and Young Adults With Dravet Syndrome

The primary study endpoint is GTCS seizure frequency. A reduction in the number and severity of seizures is anticipated.

We anticipate a reduction in myoclonic, absence, and atypical absence seizures as well.

Beverly S. Wical, M.D.

Pediatric Neurologist

Ann & Robert H Lurie Children's Hospital of Chicago

Dartmouth-Hitchcock Medical Center

Topiramate

Jefferson Headache Center

A Double-Blind, Placebo-Controlled Study Examining the Use of Topiramate in the Treatment of Cluster Headache

A Single-Center, Randomized, Double-Blind, Placebo Controlled Trial Examining the Safety and Efficacy of Topiramate in the Treatment of Subjects With Episodic or Chronic Cluster Headache.

cluster headache/seizures

Variability of the Autonomic Nervous System (ANS) During Cluster Headache (CH).

Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms

A Feasibility Clinical Trial to Evaluate High Frequency Spinal Cord Stimulation for the Treatment of Patients With Chronic Migraine

Verapamil as Therapy for Children and Young Adults With Dravet Syndrome

A Double-Blind, Placebo-Controlled Study Examining the Use of Topiramate in the Treatment of Cluster Headache

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