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The limitations of the study were that:
•
The device was only evaluated in patients diagnosed with
essential tremor, and the effectiveness of the device has
not been evaluated for tremor associated with other
conditions;
•
Effectiveness was only evaluated within one clinic visit
immediately after a 40-minute stimulation session, and it
is unknown if repeated treatment will provide better, worse
or similar benefit;
•
The active device provided stimulation that could be felt
by the patient, while the sham device was inactive; it is
therefore possible that some patients could have correctly
identified the treatment group they were in, which could
have biased study results; and
•
Many patients in the study were also taking medication for
their tremor, and it was difficult to assess the effect of the
device compared to medication.
