1082

 

 

 

 

 

Date

 

 

 

Organization

 

 

 

Location

 

 

 

Author

 

 

Indications

 

 

September 19, 2001

 

 

 

PIERRE L. LeROY, M.D., F.A.C.S.

 

 

Newark, DE

 

 

Pierre L. LeRoy, M.D., F.A.C.S.

 

 

 

pain

 

 

 

PIERRE L. LeROY, M.D., F.A.C.S.
Neurological Surgery and
Pain Management Consultant

September 19, 2001

Dr. Kirsch
Electromedical Products International, Inc.
2201 Garrett Morris Parkway
Mineral Wells, TX 76067

RE:  Alpha-Stim Therapy

Dear Dr. Kirsch:

I wish to thank your company, Electromedical Products International, Inc. for lending the Delaware Pain Clinic program the FDA approved Alpha-Stim units for clinical trials to evaluate and treat chronic, refractory neuropathic and myofacial pain syndromes, without any financial interests.

Our limited trials of ten patients who had both Somatic and Psychological diagnosis - were drug free and provided informed consent agreements.

We were very impressed they demonstrated significant clinical improvements. This group included non-operative, pre-operative, and post-operative treatments.

The results were encouraging enough to recommend a larger series for clinical trials in order to accumulate more data, to better determine efficacy to avoid more complex neuroaugmentive or ablative neurosurgical procedures by spinal and brain stimulators, and trial of post-operative patients who have significant residual pain syndromes as adjunctive therapy for those who are drug sensitive or intolerant.

Could you please organize a multi-center study for meta analysis?

Please advise me as soon as possible.

Sincerely,
Pierre L. LeRoy, M.D.
Pierre L. LeRoy, M.D., F.A.C.S.

Newark Professional Center, 249 East Main Street, Newark, Deleware 19711
Phone: (302) 736-9543, Fax: (302) 738-9508

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