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By Susan Barber Lindquist, April 3, 2017

Mayo Clinic researchers used electrical stimulation on the spinal cord and intense physical therapy to help a man intentionally move his paralyzed legs, stand and make step-like motions for the first time in three years.
The case, the result of collaboration with UCLA researchers, appears today in Mayo Clinic Proceedings. Researchers say these results offer further evidence that a combination of this technology and rehabilitation may help patients with spinal cord injuries regain control over previously paralyzed movements, such as step like actions, balance control and standing.

“We’re really excited, because our results went beyond our expectations,” says neurosurgeon Kendall Lee, MD., PH.d., principal investigator and director of Mayo Clinic’s Neural Engineering Laboratory. “These are initial findings, but the patient is continuing to make progress.”

The 26 year old patient injured his spinal cord at the sixth thoracic vertebrae in the middle of his back three years earlier. He was diagnosed with a motor complete spinal cord injury, meaning he could not move or feel anything below the middle of his torso.

The study started with the patient going through 22 weeks of physical therapy. He had three training sessions a week to prepare his muscles for attempting tasks during spinal cord stimulation. He was tested for changes regularly. Some results led researchers to characterize his injury further as discomplete suggesting dormant connections across his injury may remain.


Following physical therapy, he underwent surgery to implant an electrode in the epidural space near the spinal cord below the injured area. The electrode is connected to a computer-controlled device under the skin in the patient’s abdomen. This device, for which Mayo Clinic received permission from the U.S. Food and Drug Administration for off-label use, sends electrical current to the spinal cord, enabling the patient to create movement.

After a three-week recovery period from surgery, the patient resumed physical therapy with stimulation settings adjusted to enable movements. In the first two weeks, he intentionally was able to:
Control his muscles while lying on his side, resulting in leg movements
Make step-like motions while lying on his side and standing with partial support
Stand independently using his arms on support bars for balance


“This has really set the tone for our post-surgical rehabilitation – trying to use that function the patient recovered to drive even more return of abilities,” says Kristin Zhao, Ph.D., co-principal investigator and director of Mayo Clinic's Assistive and Restorative Technology Laboratory. 

The Mayo researchers worked closely with the team of V. Reggie Edgerton, Ph.D., at UCLA on this study, which replicates earlier research done at the University of Louisville. The Mayo study marks the first time a patient intentionally controlled previously paralyzed functions within the first two weeks of stimulation.

The data suggest that people with incomplete spinal cord injuries may be candidates for epidural stimulation therapy. However, more research is needed into how a incomplete injury contributes to recovering function.
Teams from Mayo Clinic’s departments of Neurosurgery and Physical Medicine and Rehabilitation, and the Division of Engineering collaborated on this project.
​
“While these are early results, it speaks to how Mayo Clinic researchers relentlessly pursue discoveries and innovative solutions that address the unmet needs of patients,” says Gregory Gores, M.D., executive dean of research, Mayo Clinic.  “These teams highlight Mayo Clinic’s unique culture of collaboration, which brings together scientists and physician experts who work side by side to accelerate scientific discoveries into critical advances for patient care.”


MICROCURRENT STUDIES

 Carley and WainapeL: Electrotherapy for Acceleration of Wound Healing, 1969

Summary: 30 hospital patients with non-healing ulcers were divided into two groups, one with conventional wound dressings and one with microcurrent stimulation at 300-700uA. The latter group was given 2 two hour stimulation periods per day. After 6 weeks of such treatment, the group treated with microcurrent showed a 150-250% faster healing rate with stronger scar formation, less pain and lessened infection in the treated area. 
 
Wolcott, Wheeler, Hardwicke and Rowley: Accelerated Healing of Skin Ulcers by Electrotherapy, 1969


Summary: Researchers applied microcurrent stimulation ranging from 200-800uA to a wide variety of wounds. The treated group showed 200-350% faster healing rates than the control group. There was stronger strength of scar tissue and antibacterial effects in infected wounds in the group treated with microcurrent.


Gault and Gatens: Use of Low Intensity Direct Current in Management of Skin Ulcers, 1976

Summary: 100 patient with skin ulcers were treated with microcurrent stimulation. Six of them had bacterial ulcers with one side used as controls. Stimulation of 200-800uA was applied. Patients had diagnosis ranging from burns, diabetes, fracture, and amputation. The lesions with patients treated with microcurrent showed approximately twice as fast a healing rate. 

 Cheng, and al-The Effects of Electric Current on ATP Generation, Protein synthesis and Cell Membrane Transport in Rat Skin, 1982 


Summary: Researchers used in vitro slices of rat skin to determine some of the biochemical explanations for accelerated wound healing. By applying various levels of samples, and then chemically analyzing them, they determined that skin treated at levels below 1000uA showed up to 75% higher amino acids and up to 400% more available ATP than controls, and that skin treated at levels above 1000uA  showed depressed levels of these substance.

Tomoya Ohno, Experimental Studies of Influences on Healing Process Mandibular Defect Stimulated by Microcurrent, 1982

Summary: 50uA microcurrents were applied to one side of the jaws to a group of dogs with lesions in their jaws. The other side was untreated. The dogs were examined at 3,7,14,21,28, 42, 56 days. "It seems likely that microcurrent promotes normal bone formation within the affected area and accelerates the osseous healing process. Prolonged application of electrical stimulation promotes a remarkable bone remodeling mechanism.


N. Heffernan, Comparative Effects of Microcurrent Stimulation of EEG Spectrum and Correlation Dimension, Integrative and Behavior Science, 1996

Summary: 30 subjects were selected for a study of comparing microcurrents on smoothing the effects of of EEG measurements of the brain. Subjects were randomly assigned to 3 groups- microcurrents (100uA) applied to earlobes, Trapezius of shoulder, and no stimulation. Electrodes were arranged so subjects could not tell which groups they were in. Fast Fourier Transform (FFT) and correlation from chaos analysis were used to measure results. The researcher found that microcurrent applied to the shoulder was markedly more effective in smoothing EEG patterns than earlobe or placebo.

Lambert, Marcus P. Burgess, T. Naokes: Electro membrane microurrent therapy reduces signs and symptoms of muscle damage, 2002 
​

Summary:
Thirty healthy men were recruited for a double-blind, placebo-controlled trial. The muscles of their nondominant arms were damaged using an eccentric-exercise protocol. Subjects were then randomly assigned to treatment with either microcurrent therapy or a placebo and monitored for a total of 168 hours. Data show that treatment of muscle damage with microcurrent therapy reduced the severity of the symptoms.

Park, RJ; Son, H; Kim et al, The Effect of Microcurrent Electrical Stimulation on the Foot Blood Circulation and Pain of Diabetic Neuropathy, 2011

Department of Physical Therapy, College of Rehabilitation Science, Daegu University, South Korea

Summary: This study was performed to investigate the effect of microcurrent electrical stimulation on the foot blood circulation and the degree of pain experienced by diabetes patients. Twenty nine patients with diabetic neuropathy over the age of 60 were randomly treated with an experimental group and a control group.
Both groups walked on a treadmill at a comfortable pace for 50 min/day, 5 days/week for 4 weeks, and each participant's body weight, body composition, and blood lipid were examined at the baseline and 4 weeks later.
The results show that the foot blood flow rate increment after the intervention was significantly different between the experimental group and the control group.










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