Randomized Sham-Controlled Trial of Navigated Repetitive Transcranial Magnetic Stimulation for Motor Recovery in Stroke: The NICHE Trial

 Since this was in the 3-12 month range, that is completely in the middle of spontaneous recovery. I see nothing that suggests you accounted for that. 67% compared to 65% is essentially the same response in intervention group and sham group. My conclusion would be this rTMS did nothing.

Randomized Sham-Controlled Trial of Navigated Repetitive Transcranial Magnetic Stimulation for Motor Recovery in Stroke: The NICHE Trial

 

Richard L. Harvey

,

Dylan Edwards

,

Kari Dunning

,

Felipe Fregni

,

Joel Stein

,

Jarmo Laine

,

Lynn M. Rogers

,

Ford Vox

,

Ana Durand-Sanchez

,

Marcia Bockbrader

,

Larry B. Goldstein

, … See all authors

Originally published15 Aug 2018https://doi.org/10.1161/STROKEAHA.117.020607Stroke. 2018;49:2138–2146

Abstract

Background and Purpose―

We aimed to determine whether low-frequency electric field navigated repetitive transcranial magnetic stimulation to noninjured motor cortex versus sham repetitive transcranial magnetic stimulation avoiding motor cortex could improve arm motor function in hemiplegic stroke patients when combined with motor training.

Methods―

Twelve outpatient US rehabilitation centers enrolled participants between May 2014 and December 2015. We delivered 1 Hz active or sham repetitive transcranial magnetic stimulation to noninjured motor cortex before each of eighteen 60-minute therapy sessions over a 6-week period, with outcomes measured at 1 week and 1, 3, and 6 months after end of treatment. The primary end point was the percentage of participants improving ≥5 points on upper extremity Fugl-Meyer score 6 months after end of treatment. Secondary analyses assessed changes on the upper extremity Fugl-Meyer and Action Research Arm Test and Wolf Motor Function Test and safety.

Results―

Of 199 participants, 167 completed treatment and follow-up because of early discontinuation of data collection. Upper extremity Fugl-Meyer gains were significant for experimental (P<0.001) and sham groups (P<0.001). Sixty-seven percent of the experimental group (95% CI, 58%–75%) and 65% of sham group (95% CI, 52%–76%) improved ≥5 points on 6-month upper extremity Fugl-Meyer (P=0.76). There was also no difference between experimental and sham groups in the Action Research Arm Test (P=0.80) or the Wolf Motor Function Test (P=0.55). A total of 26 serious adverse events occurred in 18 participants, with none related to the study or device, and with no difference between groups.

Conclusions―

Among patients 3 to 12 months poststroke, goal-oriented motor rehabilitation improved motor function 6 months after end of treatment. There was no difference between the active and sham repetitive transcranial magnetic stimulation trial arms.

Clinical Trial Registration―

URL: https://www.clinicaltrials.gov. Unique identifier: NCT02089464.

Researchers Testing Possible Benefits of Brain Stimulation in Stroke Rehab

I couldn't participate in one of these at the University of Minnesota because it required some volitional extension of the fingers. And since my motor control area for the fingers is dead this type of therapy is useless for me.  Try it you may like it.
http://healthnews.uc.edu/news/?/24831/

Researchers on the University of Cincinnati medical campus are testing the possible benefits of brain stimulation on hand and arm function for stroke recovery patients.

The clinical trial, known as NICHE (for Navigated Inhibitory rTMS to Contralesional Hemisphere), is recruiting participants who have had a stroke in the past year. It involves a combination of occupational therapy and a method of non-invasive brain stimulation called transcranial magnetic stimulation (TMS). (rTMS is repetitive transcranial magnetic stimulation.)

UC is one of 12 sites for the study, all in the United States. Principal investigators for the UC site are Kari Dunning, PT, PhD, an associate professor and epidemiologist in the College of Allied Health’s Department of Rehabilitation Sciences and director of the Neural Excitability, Therapeutics and Recovery (NET Recovery) lab, and Brett Kissela, MD, MS, Albert Barnes Voorheis Professor and Chair of Neurology and Rehabilitation Medicine in the College of Medicine and a member of the UC Neuroscience Institute.

"There is evidence that people who have sustained a stroke can improve arm movement following stimulation to the brain using TMS,” says Dunning. "Our aim is to test this approach and quantify the results.”

Dunning explains that TMS can reduce or increase brain activity. By using it to reduce brain activity on the uninjured side of the brain, she says, the injured side is forced to work harder and might have a better chance of recovering.

The study will use a navigated brain stimulation device manufactured by Nexstim Ltd., which is funding the trial. Dunning and Kissela report no conflicts.

Participants will be divided into two groups, one of which will receive rTMS treatment and the other receiving sham (placebo) rTMS. Both groups will receive task-oriented rehabilitation from a licensed therapist. It is a randomized, controlled, double-blinded study, which means that neither participants nor investigators know which treatment is being used.

The therapy will be provided for six weeks, and primary outcomes assessed six months later.

To qualify, participants must be 18 or older, have had their stroke three to 12 months prior to enrollment in the study and have hand and arm weakness on one side of their body. Exclusion criteria include implanted devices such as pacemakers or defibrillators, pregnancy, depression and active alcohol abuse.

The therapy and treatments are free of charge. Participants will be compensated over the follow-up period.

Nexstim Initiates Multicenter Clinical Trial on the Therapeutic Effects of Navigated TMS for Stroke Rehabilitation

I'm sure this will be interesting because they are stimulating the good side.
gitaljournal.com/pr/1980763
Nexstim has launched a multicenter double-blinded, randomized, and sham-controlled trial to determine the therapeutic effects of navigated rTMS (repetitive transcranial magnetic stimulation) for stroke rehabilitation. This cutting-edge stroke therapy combines occupational therapy with nTMS (navigated transcranial magnetic stimulation). Called the NICHE trial (Navigated Inhibitory rTMS in Contralesional Hemisphere Evaluation), this two year study will be conducted at twelve of the top rehabilitation sites in the United States.
“The trial results are showing great potential for non-invasive brain modulation and the difference Nexstim is providing is the proven Navigation to enable this approach.” - Janne Huhtala, CEO, Nexstim
Dr. Richard Harvey, Medical Director, Center for Stroke Rehabilitation, Rehabilitation Institute of Chicago (RIC), developed the protocol with Nexstim and ran the single center trial. Dr. Harvey and his team at RIC presented the trial results at the American Heart Association’s International Stroke Conference in February, ‘The Contrastim Stroke Study: Improving Hand and Arm Function After Stroke with Combined Non-Invasive Brain Stimulation and Task-Oriented Therapy’ (presentation #152).
Dr. Harvey’s study approached stroke rehabilitation through a new combination of therapies which produced significantly greater gains in patients’ motor function 6 months post stroke. The combination of non-invasive navigated transcranial magnetic stimulation (nTMS) along with occupational therapy opened the door to improving the quality of life for stroke survivors. The study showed over 80% of the active group received a clinically meaningful response rate.
Researchers working at the following trial sites, will enroll up to 200 patients, and will look to replicate the initial findings.
Arizona
Mayo Clinic
California
Ranchos Los Amigos National Rehabilitation Institute
Georgia
Shepherd Center
Illinois
Rehabilitation Institute of Chicago
Indiana
Indiana University
Massachusetts
Spaulding Rehabilitation Hospital
New York
Columbia University
Burke Rehabilitation Center
North Carolina
Duke University
Ohio
Ohio State University
University of Cincinnati
Texas
TIRR Memorial Hermann Hospital
About the Technology:
The NBS System uses stereotactic MRI-guided transcranial magnetic stimulation (TMS) to non-invasively modulate precise areas of the motor cortex. The system’s e-field based targeting tool allows the therapist to accurately locate the patients exact stimulation target using technology similar to mapping the globe with a GPS. The nTMS is used to stimulate the patient’s non-injured brain hemisphere at a low frequency. This results in down-regulation of the excitability of the healthy side and restoration of the balance between the lesioned and healthy sides, allowing the lesioned side to regain function. Adding navigation to TMS is the key to finding the exact location and orientation of the e-field of the motor area that should be inhibited by stimulation. The stimulation is then accurately repeated in every session, assuring the dose is applied to the correct place.
About Nexstim:
Founded in 2000, Nexstim is committed to improving the quality of life of patients with significant unmet clinical needs. The advanced technology providing navigation to TMS has led to Nexstim being the world leader in image-guided transcranial magnetic stimulation (TMS). Nexstim has pioneered the technology for brain diagnostics and with FDA-clearance of the Navigated Brain Stimulation (NBS) System for non-invasive pre-surgical mapping. NBS is recognized as the emerging standard for pre-operative direct functional mapping. Nexstim’s NBS System enables treatment of brain injury and disease using rTMS with accurate and repeatable 3D-guidance of therapeutic electrical field.
Nexstim’s non-invasive Navigated Brain Stimulation System is not approved by the Food and Drug Administration for therapy in commercial use in the United States and is available to select physician for investigational use only.

Nexstim
Jaime Bloom
+1-404-358-7440
j.bloom@nexstim.com
or
Janne Huhtala, CEO
+358 40 8615046
janne.huhtala@nexstim.com

Read more: http://www.digitaljournal.com/pr/1980763#ixzz34MzIpNLa