Methods and Systems for Facilitating Clinical Trials
First Claim
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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.
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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.
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Citations
27 Claims
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1. A method of evaluating an experimental therapy for a patient population in a clinical trial, the method comprising:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A method of evaluating efficacy of an experimental pharmacological agent on a patient population in a clinical trial, the method comprising:
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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. - View Dependent Claims (16, 17, 18, 19, 20, 21, 22, 23, 24)
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25. A method of evaluating an experimental therapy for a patient population in a clinical trial, the method comprising:
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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. - View Dependent Claims (26)
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27. A method of evaluating an experimental anti-epileptic drug (AED) therapy for a patient population in a clinical trial, the method comprising:
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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.
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Specification