Methods and Systems for Facilitating Clinical Trials

• US 20080021341A1
• Filed: 06/21/2007
• Published: 01/24/2008
• Est. Priority Date: 06/23/2006
• Status: Abandoned Application

• Current Assignee: Cyberonics, Inc
• Original Assignee: NeuroVista Corporation
• Inventors: Leyde, Kent, Harris, John
• Application Number:
  US11/766,756
• Publication Number:
  US 20080021341A1
• Time in Patent Office: Days
• US Class Current: 600/544
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/372 Analysis of electroencephalograms
• CPC Class Codes: A61B 5/386 Accessories or supplementary instruments therefor
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna

Abstract

The present invention provides methods and systems for improving clinical trials of experimental therapies. The present invention uses minimally invasive, leadless implantable devices that facilitate long term monitoring of a physiological signal (e.g., neural signals) from a patient population which may provide an indication of the effect of the experimental therapy on the patient population. In preferred embodiments, neural signals are sampled from the patients in the patient population with an externally powered, leadless implanted device and are transmitted to an external device for further processing.

Claims

1. A method of evaluating an experimental therapy for a patient population in a clinical trial, the method comprising:

minimally invasively implanting patients with one or more devices that are configured to measure a physiological signal from the patients;

processing the physiological signal from the patients for a first time period to obtain a first patient data;

measuring the physiological signal from the patients after the patients have commenced the experimental therapy;

processing the physiological signal that was measured after the commencement of the experimental therapy to obtain a second patient data; and

evaluating the experimental therapy by analyzing the first patient data and the second patient data.

2. The method of claim 1 wherein the experimental therapy comprises a pharmacological agent.

3. The method of claim 1 wherein comparing is performed to evaluate the efficacy of the experimental therapy in the patient population.

4. The method of claim 1 wherein comparing is performed to evaluate dosing requirements of the experimental therapy for the patient population.

5. The method of claim 1 wherein comparing is performed to evaluate toxicity of the experimental therapy for the patient population.

6. The method of claim 1 wherein comparing is performed to evaluate long-term adverse effects of the experimental therapy on the patient population.

7. The method of claim 1 wherein the experimental therapy comprises vagus nerve stimulation.

8. The method of claim 1 wherein the experimental therapy comprises brain stimulation.

9. The method of claim 1 wherein minimally invasively implanting patients with one or more devices comprises implanting one or more leadless devices between at least one layer of the scalp and the skull.

10. The method of claim 1 further comprising:

transcutaneously transmitting data that is indicative of the measured physiological signal through a wireless communication link to a device that is external to the patient'"'"'s body; and

storing the data that is indicative of the measured physiological signal in a memory.

11. The method of claim 1 wherein the experimental therapy is for managing epilepsy and the physiological signal comprises an EEG signal.

12. The method of claim 11 wherein processing the physiological signal from the patient for a first time period comprises obtaining a baseline seizure activity that comprises at least one of a number a clinical seizures during the first time period, a number of sub-clinical seizures during the first time period, seizure duration, seizure patterns, seizure frequency, and time of seizure occurrence.

13. The method of claim 12 wherein evaluating the experimental therapy by comparing the first patient data with the second patient data comprises comparing baseline seizure activity with seizure activity after commencement of the experimental therapy.

14. The method of claim 1 further comprising:

changing at least one parameter of the experimental therapy;

measuring the physiological signal from the patients after the patients have commenced the experimental therapy with the at least one changed parameter for a third time period;

processing the physiological signal that was measured during the third time period to obtain a third patient data; and

evaluating the experimental therapy by comparing the third patient data with at least one of the first patient data and the second patient data.

15. A method of evaluating efficacy of an experimental pharmacological agent on a patient population in a clinical trial, the method comprising:

enrolling a patient population in the clinical trial;

implanting the patient population with one or more leadless devices between a patient'"'"'s skull and scalp that are configured to measure brain activity signals;

measuring brain activity signals for a baseline time period;

processing the brain activity signals for the baseline time period to obtain baseline data of the patient population;

instructing the patient population to commence a treatment regimen of the pharmacological agent;

measuring brain activity signals in the patient population for a desired time period after the patient population has commenced the pharmacological agent treatment regimen;

processing the brain activity signals in the patient population for the desired time period to obtain follow-up data of the patient population; and

evaluating the pharmacological agent by comparing the baseline data and the follow-up data.

16. The method of claim 15 wherein evaluating the pharmacological agent comprises assessing the efficacy of the pharmacological agent in the patient population.

17. The method of claim 15 wherein evaluating the pharmacological agent comprises assessing dosing requirements of the pharmacological agent for the patient population.

18. The method of claim 15 wherein evaluating the pharmacological agent comprises assessing toxicity of the pharmacological agent for the patient population.

19. The method of claim 15 wherein evaluating the pharmacological agent comprises assessing long-term adverse effects of the pharmacological agent on the patient population.

20. The method of claim 15 wherein the pharmacological agent is for managing seizures.

21. The method of claim 20 wherein processing the brain activity for the baseline time period to obtain baseline data of the patient population comprises:

transcutaneously transmitting the measured brain activity signals through a wireless communication link to a device that is external to the patient'"'"'s body; and

extracting seizure activity data from the brain activity signals.

22. The method of claim 21 wherein the seizure activity data comprises at least one of:

a number a clinical seizures during the baseline time period, a number of sub-clinical seizures during the baseline time period, average seizure duration, seizure patterns, seizure frequency, and time of seizure occurrence.

23. The method of claim 20 wherein evaluating the pharmacological agent by comparing the baseline data with the follow-up data comprises comparing baseline seizure activity with seizure activity in the follow-up data.

24. The method of claim 15 further comprising:

changing at least one parameter of the pharmacological agent;

measuring the brain activity signals from the patients after the patients have commenced the treatment regimen with the pharmacological agent with the at least one changed parameter;

processing brain activity signals that were measured after the commencement of the treatment regimen with the pharmacological agent with the at least one changed parameter to obtain subsequent patient data; and

evaluating the pharmacological agent by comparing the subsequent patient data with at least one of the baseline data and the follow-up data.

25. A method of evaluating an experimental therapy for a patient population in a clinical trial, the method comprising:

minimally invasively implanting the patient population with one or more devices that are configured to measure a physiological signal from a patient;

processing the physiological signal from the patient population for a baseline time period to obtain a first patient data;

commencing a placebo therapy in a control group of the patient population;

commencing the experimental therapy in an intervention group of the patient population;

measuring the physiological signal from the control group and the intervention group for a second time period after the patients'"'"' have commenced the placebo therapy and experimental therapy, respectively;

processing the physiological signal obtained during the second time period to obtain a second patient data; and

evaluating the experimental therapy by analyzing the first patient data and the second patient for both the control group and the intervention group.

26. The method of claim 25 wherein minimally invasively implanting the patient population comprises placing one or more device in between the skull and the scalp.

27. A method of evaluating an experimental anti-epileptic drug (AED) therapy for a patient population in a clinical trial, the method comprising:

enrolling a patient population in the clinical trial;

minimally invasively implanting one or more devices between the patient'"'"'s skull and scalp that are configured to substantially continuously sample an EEG signal from the patient for a baseline period;

wirelessly transmitting a signal encoded with the sampled EEG signals to a portable device that is external to the patient;

processing the EEG signal from the patients to obtain a seizure activity baseline for the patients in the patient population;

separating the patient population into a control group and an intervention group;

commencing a placebo AED therapy in the control group of the patient population;

commencing the experimental AED therapy in the intervention group of the patient population;

substantially continuously sampling the EEG signals from the control group and the intervention group with the implanted one or more devices for a selected time period after the patients have commenced the placebo therapy and experimental therapy, respectively;

processing the EEG signal from the patients from the selected time period to obtain a seizure activity outcome data; and

evaluating the experimental AED therapy by comparing the baseline seizure activity data with the seizure activity outcome data for both the control group and the intervention group.