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Deep brain stimulation promotes stroke recovery in world-first study



Using deep brain stimulation (DBS) to target the area of the brain responsible for voluntary movements is safe and feasible for promoting post-stroke rehabilitation, according to a first-in-human study.

The single-arm, open-label study, EDEN trial was conducted at Cleveland Clinic, Ohio.

The 12 participants had chronic, moderate to severe hemiparesis (weakness) in the arm and/or hand following unilateral middle cerebral artery stroke.

Dr Andre Machado Machado, Chair of the Neurological Institute at Cleveland Clinic, said:

“We hypothesized that stimulating the dentatothalamocortical pathway, which connects the cerebellum and the cortex, would facilitate the spared perilesional cortex following ischemic stroke.

“We further proposed that this stimulation, when paired with physical training, would promote greater functional restoration than could be achieved with physical training alone.

“That is what we observed in this phase I study, as patients with even minimal residual distal function responded well.”

All patients began physical rehabilitation prior to the implantation of a DBS lead at the dentate nucleus on the opposite side of the brain to where their stroke occurred.

After implantation, the patients underwent a further two months of rehabilitation, followed by a month of DBS programming over a number of sessions.

This was followed by at least four months of combined rehabilitation and DBS.

All 12 of the patients completed the study and there were no deaths, hemorrhages, infections or other major complications relating to the procedure.

A ≥ 4.5-point improvement on the FMA-UE scale was achieved in nine out of 12 patients, with a mean FMA-UE score of 11.8 points.

The greatest improvement was seen among the seven patients with at least minimal distal motor function. The mean improvement of 16.4 points was associated with significant improvement in activities of daily living (ADLs).

“This suggests that patients who have a bit of the neuronal pathway preserved offer us more to work with,” Dr. Machado said. “There appear to be some neurons surviving that the stimulation and physical training can activate and boost.”

Significant improvements to quality of life were reported in the weeks and months after the combined therapies.

One patient reported that they had regained the ability to write using a marker while another could throw a ball with her affected hand.

Cleveland Clinic is now planning a randomised, sham-controlled study of up to 40 post-stroke patients.

The study will be limited to patients with at least modest residual distal upper extremity function who benefited most in the original group.

Dr. Machado said:

“About half of chronic stroke patients have a residual neurological deficit severe enough to require assistance with ADLs, even after extensive rehabilitative training.

“We clearly need a tool that enhances the effects of physical training. DBS of the dentate nucleus shows encouraging promise to be such a tool. We are eager to investigate it further.”