TY - JOUR
T1 - Square biphasic pulse deep brain stimulation for essential tremor
T2 - The BiP tremor study
AU - De Jesus, Sol
AU - Almeida, Leonardo
AU - Shahgholi, Leili
AU - Martinez-Ramirez, Daniel
AU - Roper, Jaimie
AU - Hass, Chris J.
AU - Akbar, Umer
AU - Wagle Shukla, Aparna
AU - Raike, Robert S.
AU - Okun, Michael S.
N1 - Funding Information:
RR is a paid employee of Medtronic Neuromodulation Global Research. MSO serves as a consultant for the National Parkinson Foundation, and has received research grants from NIH, NPF, the Michael J. Fox Foundation, the Parkinson Alliance, Smallwood Foundation, the Bachmann-Strauss Foundation, the Tourette Syndrome Association, and the UF Foundation. MSO's DBS research is supported by: R01 NR014852. MSO has previously received honoraria, but in the past >60 months has received no support from industry. MSO has received royalties for publications with Demos, Manson, Amazon, Smashwords, Books4Patients, and Cambridge (movement disorders books). MSO is an associate editor for New England Journal of Medicine Journal Watch Neurology. MSO has participated in CME and educational activities on movement disorders (in the last 36) months sponsored by PeerView, Prime, QuantiaMD, WebMD, MedNet, Henry Stewart, and by Vanderbilt University. The institution and not MSO receives grants from Medtronic, Abbvie, Allergan, and ANS/St. Jude, and the PI has no financial interest in these grants. MSO has participated as a site PI and/or co-I for several NIH, foundation, and industry sponsored trials over the years but has not received honoraria.
Funding Information:
RR is a paid employee of Medtronic Neuromodulation Global Research. MSO serves as a consultant for the National Parkinson Foundation, and has received research grants from NIH , NPF , the Michael J. Fox Foundation , the Parkinson Alliance , Smallwood Foundation , the Bachmann-Strauss Foundation , the Tourette Syndrome Association , and the UF Foundation . MSO's DBS research is supported by: R01 NR014852 . MSO has previously received honoraria, but in the past >60 months has received no support from industry. MSO has received royalties for publications with Demos, Manson, Amazon, Smashwords, Books4Patients, and Cambridge (movement disorders books). MSO is an associate editor for New England Journal of Medicine Journal Watch Neurology. MSO has participated in CME and educational activities on movement disorders (in the last 36) months sponsored by PeerView , Prime , QuantiaMD , WebMD , MedNet , Henry Stewart , and by Vanderbilt University . The institution and not MSO receives grants from Medtronic , Abbvie , Allergan , and ANS/St. Jude , and the PI has no financial interest in these grants. MSO has participated as a site PI and/or co-I for several NIH, foundation, and industry sponsored trials over the years but has not received honoraria.
Publisher Copyright:
© 2017
Copyright:
Copyright 2019 Elsevier B.V., All rights reserved.
PY - 2018/1
Y1 - 2018/1
N2 - Background Conventional deep brain stimulation (DBS) utilizes regular, high frequency pulses to treat medication-refractory symptoms in essential tremor (ET). Modifications of DBS pulse shape to achieve improved effectiveness is a promising approach. Objectives The current study assessed the safety, tolerability and effectiveness of square biphasic pulse shaping as an alternative to conventional ET DBS. Methods This pilot study compared biphasic pulses (BiP) versus conventional DBS pulses (ClinDBS). Eleven ET subjects with clinically optimized ventralis intermedius nucleus DBS were enrolled. Objective measures were obtained over 3 h while ON BiP stimulation. Results There was observed benefit in the Fahn-Tolosa Tremor Rating Scale (TRS) for BiP conditions when compared to the DBS off condition and to ClinDBS setting. Total TRS scores during the DBS OFF condition (28.5 IQR = 24.5–35.25) were significantly higher than the other time points. Following active DBS, TRS improved to (20 IQR = 13.8–24.3) at ClinDBS setting and to (16.5 IQR = 12–20.75) at the 3 h period ON BiP stimulation (p = 0.001). Accelerometer recordings revealed improvement in tremor at rest (χ 2 = 16.1, p = 0.006), posture (χ 2 = 15.9, p = 0.007) and with action (χ 2 = 32.1, p=<0.001) when comparing median total scores at ClinDBS and OFF DBS conditions to 3 h ON BiP stimulation. There were no adverse effects and gait was not impacted. Conclusion BiP was safe, tolerable and effective on the tremor symptoms when tested up to 3 h. This study demonstrated the feasibility of applying a novel DBS waveform in the clinic setting. Larger prospective studies with longer clinical follow-up will be required.
AB - Background Conventional deep brain stimulation (DBS) utilizes regular, high frequency pulses to treat medication-refractory symptoms in essential tremor (ET). Modifications of DBS pulse shape to achieve improved effectiveness is a promising approach. Objectives The current study assessed the safety, tolerability and effectiveness of square biphasic pulse shaping as an alternative to conventional ET DBS. Methods This pilot study compared biphasic pulses (BiP) versus conventional DBS pulses (ClinDBS). Eleven ET subjects with clinically optimized ventralis intermedius nucleus DBS were enrolled. Objective measures were obtained over 3 h while ON BiP stimulation. Results There was observed benefit in the Fahn-Tolosa Tremor Rating Scale (TRS) for BiP conditions when compared to the DBS off condition and to ClinDBS setting. Total TRS scores during the DBS OFF condition (28.5 IQR = 24.5–35.25) were significantly higher than the other time points. Following active DBS, TRS improved to (20 IQR = 13.8–24.3) at ClinDBS setting and to (16.5 IQR = 12–20.75) at the 3 h period ON BiP stimulation (p = 0.001). Accelerometer recordings revealed improvement in tremor at rest (χ 2 = 16.1, p = 0.006), posture (χ 2 = 15.9, p = 0.007) and with action (χ 2 = 32.1, p=<0.001) when comparing median total scores at ClinDBS and OFF DBS conditions to 3 h ON BiP stimulation. There were no adverse effects and gait was not impacted. Conclusion BiP was safe, tolerable and effective on the tremor symptoms when tested up to 3 h. This study demonstrated the feasibility of applying a novel DBS waveform in the clinic setting. Larger prospective studies with longer clinical follow-up will be required.
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U2 - 10.1016/j.parkreldis.2017.10.015
DO - 10.1016/j.parkreldis.2017.10.015
M3 - Article
C2 - 29102253
AN - SCOPUS:85032330123
VL - 46
SP - 41
EP - 46
JO - Parkinsonism and Related Disorders
JF - Parkinsonism and Related Disorders
SN - 1353-8020
ER -