Pilot study of spinal cord stimulation shows promise for gait disturbance in Parkinson’s

Key takeaways:

• Burst stimulation yielded more positive results compared with tonic stimulation.
• No serious adverse events were reported; however, five individuals reported perioperative pain.

ORLANDO, Fla. — A pilot study of direct spinal cord stimulation showed promise for improving motor function in a small cohort of individuals with gait freezing in Parkinson’s disease, according to a presenter.

“Gait disturbances in Parkinson’s disease cause significant issues in quality of life, morbidity and mortality and there are currently no treatments, pharmacological or surgical,” Nora Vanegas-Arroyave, MD, associate professor of neurology and director of neuromodulation research at Baylor College of Medicine, said at the American Neurological Association annual meeting.

Vanegas-Arroyave and colleagues collaborated on a pilot study to assess safety, efficacy and tolerability of spinal cord stimulation to address freezing of gait in PD.

The randomized, blinded clinical trial involved 10 individuals with PD, with evidence of gait freezing in both “on” and “off” states, who were given spinal cord stimulation and sham therapy. Treatment was given via the Abbott octrode neurostimulation system, with leads placed into the T2 to T4 space in the upper thoracic spine and the implant placed directly into the spinal column, providing both tonic and burst stimulation to participants.

After a series of initial consultations over 4 weeks, the devices were implanted and over the next 8 weeks, all participants received sham treatment. After a 1-week washout interval, the second program of treatment involved all participants randomized to receive either burst or tonic stimulation for 8 weeks, with a second 1-week washout period afterward.

Participants then had the option to enter an 8-month open-label phase where they were aware of the kind of stimulation received.

Preliminary data from four participants showed that scores on the MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III decreased more from baseline through the two burst stimulation treatment periods compared with tonic in both “on” and “off” states, while scores on the New Freezing of Gait Questionnaire descended significantly from baseline in burst stimulation compared with tonic. One participant also showed significant improvement in the timed 10-meter walk test with burst stimulation compared with the other three combined.

Additionally, no serious adverse events were reported, although five of six individuals reported perioperative pain.

In their homes, participants recorded an increase of 36.8% in stand-to-walk ratio with spinal cord stimulation from baseline, with an increase of 55.7% in sit-to-stand ratio.

These data stand in contrast to trials in a laboratory setting, where the average timed 10-meter walk increased from 4.52 seconds to 4.85 seconds with the stimulation active.

“I think we need to start thinking in a different way when we talk about gait,” Vanegas-Arroyave said. “Additional evidence is needed to evaluate the benefits of spinal cord stimulation.”