DEVICES AND METHODS FOR USING MECHANICAL AFFECTIVE TOUCH THERAPY TO IMPROVE FOCUS, CONCENTRATION, LEARNING CAPACITY, VISUAL MEMORY, NEW LEARNING, SUSTAINED ATTENTION, COGNITION & INTEROCEPTION IN HUMANS

Abstract

Methods and devices that improve focus, concentration, learning capacity, visual memory, new learning, sustained attention, cognition and/or interoception in a human using mechanical affective touch therapy are provided. In one embodiment, the method comprises delivering to a human body transcutaneous mechanical vibrations having a frequency of less than 20 Hz for at least 10 minutes, at least 2 times per day, for a period of at least 4 weeks, thereby providing the human with transcutaneous mechanical stimulation that improves focus, concentration, learning capacity, visual memory, new learning, sustained attention, cognition and interoception in that human.

Claims

1. A device for improving focus, concentration, learning capacity, visual memory, new learning, sustained attention, cognition and/or interoception in a human, the device comprising: one or more mechanical transducers capable of creating transcutaneous mechanical vibrations on the body of a human; one or more batteries; one or more controller boards that control the output of the mechanical transducers; wherein the one or more mechanical transducers, the one or more batteries and the one or more controller boards are in communication; wherein the controller board controls the output of the one or more mechanical transducers, thereby producing transcutaneous mechanical vibrations for a human and wherein when the device provides transcutaneous mechanical vibrations in proximity to the temporal bone of the human's head.

2. The device of claim 1, wherein the frequency of the one or more waveform is less than 20 Hz.

3. The device of claim 1, wherein the frequency of the one or more waveforms is approximately 10 Hz.

4. The device of claim 1, wherein the one or more waveforms are isochronic.

5. The device of claim 1, wherein the device delivers mechanical vibrations in proximity to the temporal bone for at least 10 minutes per day.

6. The device of claim 5, wherein the device delivers mechanical vibrations in proximity to the temporal bone at least one time per day for a period of at least 4 weeks.

7. A device for improving focus, concentration, learning capacity, visual memory, new learning, sustained attention, cognition and/or interoception in a human, the device comprising: one or more mechanical transducers, one or more batteries, and one or more sinusoidal waveforms and one or more controller boards that control at least the one or more sinusoidal waveforms output through the mechanical transducers; wherein the one or more mechanical transducers, the one or more batteries and the one or more controller boards are in communication; wherein the controller board controls sinusoidal waveform output through the one or more mechanical transducers, thereby producing mechanical vibrations for a human and wherein when the device is adapted to provide mechanical vibrations in proximity to the temporal bone of the human's head.

8. The device of claim 7, wherein the frequency of the one or more waveform is less than 20 Hz.

9. The device of claim 7, wherein the frequency of the one or more waveforms is approximately 10 Hz.

10. The device of claim 7, wherein the one or more waveforms are isochronic.

11. The device of claim 7, wherein the device delivers mechanical vibrations in proximity to the temporal bone for at least 20 minutes per day.

12. The device of claim 11, wherein the device delivers mechanical vibrations in proximity to the temporal bone at least 2 times per day for a period of at least 4 weeks.

13. A device for improving focus, concentration, learning capacity, visual memory, new learning, sustained attention, cognition and interoception in a human, the device comprising: one or more mechanical transducers that create mechanical vibrations, one or more batteries, and one or more controller boards that control the one or more mechanical transducers; wherein the one or more mechanical transducers, the one or more batteries and the one or more controller boards are in communication with each other; wherein the controller board controls the output through the one or more mechanical transducers, thereby producing mechanical vibrations and wherein the device provides transcutaneous mechanical vibrations in proximity to the temporal bone of the human's head.

14. The device of claim 13, wherein the frequency is less than 20 Hz.

15. The device of claim 13, wherein the frequency is approximately 10 Hz.

16. The device of claim 13, wherein the waveforms of the mechanical vibrations are isochronic.

17. The device of claim 13, wherein the device delivers mechanical vibrations in proximity to the temporal bone for at least 20 minutes per day at least 2 times per day for a period of at least 4 weeks.

18. A method of improving focus, concentration, learning capacity, visual memory, new learning, sustained attention, cognition and/or interoception in a human, the method comprising: delivering to a human body transcutaneous mechanical vibrations having a frequency of less than 20 Hz for at least 10 minutes per day at least 2 times per day for a period of at least 4 weeks.

19. The method of claim 18, wherein the frequency is approximately 10 Hz.

20. The method of claim 18, wherein the waveforms of the mechanical vibrations are isochronic.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0089] The foregoing and other objects, aspects, features, and advantages of the present disclosure will become more apparent and better understood by referring to the following description taken in conjunction with the accompanying drawings, in which:

[0090] FIG. 1 shows an image of the COVE® device used in the studies shown and described herein.

[0091] FIG. 2 shows another image of the COVE® device used in the studies shown and described herein.

[0092] FIG. 3 shows examples of waveforms used in accordance with at least some embodiments of the present invention described herein.

[0093] FIG. 4 is a table showing demographic information regarding the participants of one of the studies shown and described herein.

[0094] FIG. 5 is a timeline of key aspects of the one of the study shown and described herein.

[0095] FIG. 6 is a table summarizing the PAL Task outcome measures and related details.

[0096] FIG. 7 is a table summarizing the RVP Task outcome measures and related details.

[0097] FIG. 8 is an image defining the dimensions of interoception assessed (MAIA).

[0098] FIG. 9 is a chart detailing the 1-Item Cognitive Rating questions related to focus, concentration, and learning capacity, asked of participants of the study disclosed herein.

[0099] FIG. 10 is a graph of the Average PAL Task First Attempt Memory Scores (PALFAMS) for a 10 Hz sample.

[0100] FIG. 11 is a graph of the Average PAL Task Total Errors vs Total Errors Adjusted for a 10 Hz sample.

[0101] FIG. 12 is a graph of the Average PAL Task Total Errors vs Total Errors Adjusted (6 Patterns) for a 10 Hz sample.

[0102] FIG. 13 is a graph of the Average PAL Task Total Errors vs Total Errors Adjusted (8 Patterns) for a 10 Hz sample.

[0103] FIG. 14 is a graph of the Average Proficiency for Detecting Target Sequences in the RVP Task (RVPA) for a 10 Hz sample.

[0104] FIG. 15 is a graph of the Average RVP Task Median Response Latency (RVPMDL) for a 10 Hz sample.

[0105] FIG. 16 is a graph of the Average RVP Task Total Hits (RVPTH) for a 10 Hz sample.

[0106] FIG. 17 is a graph of the Average RVP Task Total Misses (RVPTM) for a 10 Hz sample.

[0107] FIG. 18 is a graph of Average Focus Ratings for a 10 Hz sample.

[0108] FIG. 19 is a graph of Average Concentration Ratings for a 10 Hz sample.

[0109] FIG. 20 is a graph of Average Learning Capacity Ratings for a 10 Hz sample.

[0110] FIG. 21 is a graph of the Average Cognitive Rating Scores for a 10 Hz sample.

[0111] FIG. 22 is a graph of the Average MAIA Scores for a 10 Hz sample.

[0112] FIG. 23 is a graph of the Average Percent Change in MAIA Scores for a 10 Hz sample.

[0113] FIG. 24 is a graph of the Average PAL Task First Attempt Memory Scores (PALFAMS) for a 20 Hz sample.

[0114] FIG. 25 is a graph of the Average PAL Total Errors vs Total Errors Adjusted for a 20 Hz sample.

[0115] FIG. 26 is a graph of the Average Proficiency for Detecting Target Sequences in the RVP Task (RVPA) for a 20 Hz sample.

[0116] FIG. 27 is a graph of the Average RVP Task Median Response Latency (RVPMDL) for a 20 Hz sample.

[0117] FIG. 28 is a graph of the Average RVP Task Total Hits (RVPTH) for a 20 Hz sample.

[0118] FIG. 29 is a graph of the Average RVP Task Total Misses (RVPTM) for a 20 Hz sample.

[0119] FIG. 30 is a graph of Average Focus Ratings for a 20 Hz sample.

[0120] FIG. 31 is a graph of Average Concentration Ratings for a 20 Hz sample.

[0121] FIG. 32 is a graph of the Average Learning Capacity Ratings for a 20 Hz sample.

[0122] FIG. 33 is a graph of the Average Cognitive Rating Scores for a 20 Hz sample.

[0123] FIG. 34 is a graph of the Average MAIA Scores for a 20 Hz sample.

[0124] FIG. 35 is a graph of the Average Percent Change in MAIA Scores for a 20 Hz sample.

DETAILED DESCRIPTION

[0125] A study was done to determine the effect the devices and methods disclosed herein on improving focus, concentration, learning capacity, visual memory, new learning, sustained attention, cognition and/or interoception in a human. As a result, study participants were identified and 32 participants enrolled. Study visits were completed virtually, participants were given a COVE® device, and participated in an instructional visit where the device was then calibrated prior to at home use, along with instructions to use the device two times daily. Cognitive assessments were administered pre and post 30 days of device use. The following information was obtained and tests performed.

[0126] ACS=Attention Control Scale, a 20-item self-report measure of attentional control (healthy average=˜50) used to screen individuals for study eligibility

[0127] Paired Associates Learning (PAL) Task. 8-minute cognitive task assessing visual memory and new learning.

[0128] PAL task performance results demonstrated that after 30 days of using the COVE® device, there was an observable improvement in visual memory and new learning in a 10 Hz sample (n=15). As shown in the results and FIGS provided herein, there was 39% increase in the group's visual memory and new learning, when accurately recalling pattern location (PALFAMS). Participants (n=15) also made fewer errors (PALTE), and were able to reach the highest level of the task when compared to baseline (PALTE vs PALTEA). On average, PAL task performance in a 20 Hz sample (n=16) did not improve after 30 days of using the COVE® device, indicating that visual memory and new learning were not affected by mechanical stimulation of 20 Hz.

[0129] Rapid Visual Information Processing (RVP) Task. 7-minute cognitive task assessing sustained attention.

[0130] RVP task performance results demonstrated that after 30 days of using the COVE® device, there was also an observable improvement in sustained attention for both 10 Hz and 20 Hz samples. Participants were better at detecting target sequences (RVPA), responded faster (RVPMDL), provided more accurate responses (RVPTH) and missed less target sequences (RVPTM) as indicated by the results of the aforementioned tests.

[0131] Study participants also completed self-reported 1-item cognitive ratings, in which participants are asked to rate their ability to focus, concentrate, and learn. On average, after 30 days of using the COVE® device, participants in both 10 Hz and 20 Hz samples reported an overall improvement in focus, concentration, and learning capacity. In a 10 Hz sample (n=15), Focus increased by 39%, Concentration increased by 16%, Learning Capacity increased by 7.5%. In a 20 Hz sample (n=16), Focus increased by 49%, Concentration increased by 51%, and Learning Capacity increased by 22%. On average, participants in both 10 Hz and 20 Hz samples were able to maintain their improvements in focus, for at least 30 days following the study, as focus ratings did not return to baseline at follow up.

[0132] As the results disclosed herein demonstrate, on average, after using the COVE® device for 30 days, participants in a 10 Hz sample (n=15) showed an overall improvement in cognition: visual memory, new learning, and sustained attention improved, measured by cognitive task performance; and focus, concentration and learning capacity improved, measured by self-reported 1-item cognitive ratings.

[0133] These results demonstrate that the device and methods disclosed herein provide a positive improvement in focus, concentration, learning capacity, visual memory, new learning, sustained attention, cognition and interoception.