Our research explores the application of the relatively novel TPS method. This is a non-invasive, neuromodulation therapy using shock waves, aiming to gather real world data on its safety and effects across different Alzheimer's stages. Our study demonstrated TPS is safe and could be a promising add-on therapy for Alzheimer's patients, showing significant cognitive and emotional improvements, even in moderate to severe cases.
Our protocol also targets severely affected patients, demonstrating that they too can benefit from TPS. And that emphasizes the potential efficiency across all disease stages, though our sample size was small and a control group is needed. Our future research focuses on analyzing long-term data collected over one year to assess sustained TPS effects.
Additionally, we are establishing a German registry to systematically evaluate treatment safety and we are considering adjustment to the stimulation protocol and target areas. To begin, press the standby button on the front panel to initialize the TPS device. Position the patient comfortably with next support, if needed.
Make the patient wear recognition glasses with detection lenses and secure them using tape or a strap. Set up and align the camera to ensure the patient's head is fully visible for tracking and calibration. Follow the onscreen instructions to complete the high voltage test, and press the trigger button on the handheld applicator when prompted.
To prepare the handpiece, apply a drop of silicone oil onto the handpiece membrane. Attach the prefilled coupling membrane to the handpiece and secure it to ensure optimal performance. Load the patient's required MRI data by inserting the external storage device containing the data into the system's USB port.
To create the patient profile, select New Patient, and enter the patient's information. The patient's full name and date of birth are automatically retrieved from the metadata on the MRICD. Once the pre-configured Alzheimer's disease protocol is selected, set energy level to 0.2 millijoules per square millimeter, frequency to four Hertz, and pulses to 6, 000 per session.
Scroll through the loaded MRI images to verify that all anatomical structures are sharp and well-defined, without any motion artifacts. Use the calibration pen to conduct a three point calibration by moving from the forehead to the back of the head, from ear to ear, and performing circular or zigzag motions across the top of the head. Ensure the detection lenses remain visible to the camera at all times.
Confirm the 3D head model on the screen aligns correctly with the patient's head by rotating it to verify contact points. Define treatment regions according to the patient's needs. Use the MRI images and specific anatomical landmarks of the brain to define the regions to be stimulated.
Adjust the size, shape, and number of treatment regions on the display. Then adjust the region's dimensions using onscreen controls. Button A for depth adjustments, button B for width adjustments, and button C for height adjustments.
Save the settings once done. Select Treatment Mode on the device and verify the proper prefilled membrane attachment. Apply ultrasound gel to the patient's scalp to ensure efficient energy transmission.
Hold the handpiece perpendicular to the scalp and move it evenly across the surface. Monitor the stimulation and treat each region until the target areas on the display turn green, indicating proper coverage. To conclude the session, press the Stop button.
Clean the equipment by wiping the handpiece and detachable membrane with approved non-alcohol based wipes. Then gently clean the patient's scalp and dry their hair as needed. Advise the patient to remain nearby for 10 to 15 minutes to check for delayed side effects.
Stay hydrated and avoid intense physical activity for the day. Transcranial pulse stimulation significantly improved Alzheimer's disease symptoms, as indicated by a decrease in ADAS total scores, from 30.2 to 25.8, and ADAS cog scores from 25.8 to 23.3. Individual patient data demonstrated varying improvements with an overall improvement of 15.76%in ADAS total scores and 8.65%in ADAS cog scores.
