Trial Outcomes & Findings for Effects of Dexmedetomidine on Activity in the Subthalamic Nucleus (NCT NCT01721460)

Results Overview

We calculated the root mean square (RMS) of the high frequency electrical activity. This is a common measure for the spiking rate of the population of neurons in the vicinity of the electrode tip. This Measure has been previously described as a useful measure to determine the target location during deep brain stimulation (DBS) procedures. We calculated the change in RMS inside the STN between baseline and peak sedation. For each subject we normalized the RMS to the RMS of the electrical activity outside the nucleus. This is done to eliminate the effects of noise and variability in electrode resistance. Thus, the normalized RMS is a pure number with no units.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

6 participants

Primary outcome timeframe

20-35 minutes following drug administration

Results posted on

2017-12-08

Participant Flow

Participant milestones

Participant milestones
Measure	Dexmedetomidine During MER Administration of dexmedetomidine during the Microelectrode recording (MER) part of subthalamic nucleus (STN) electrode implantation surgery. Dexmedetomidine: Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved.
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Dexmedetomidine on Activity in the Subthalamic Nucleus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexmedetomidine During MER n=6 Participants Administration of dexmedetomidine during the Microelectrode recording part of STN electrode implantation surgery. Dexmedetomidine: Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved.
Age, Continuous	61.5 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 20-35 minutes following drug administration

Population: All participants had the normalized RMS of the electrical activity calculated during control period, and under maximal sedation, and the difference between the two was calculated and normalized.

We calculated the root mean square (RMS) of the high frequency electrical activity. This is a common measure for the spiking rate of the population of neurons in the vicinity of the electrode tip. This Measure has been previously described as a useful measure to determine the target location during deep brain stimulation (DBS) procedures. We calculated the change in RMS inside the STN between baseline and peak sedation. For each subject we normalized the RMS to the RMS of the electrical activity outside the nucleus. This is done to eliminate the effects of noise and variability in electrode resistance. Thus, the normalized RMS is a pure number with no units.

Outcome measures

Outcome measures
Measure	Dexmedetomidine Modulation of MER n=5 Participants Change in RMS value between baseline (awake) and maximal sedation during dexmedetomidine administration.
Change in Average Population Spiking Activity	42.8 Percent change Standard Deviation 12.7

SECONDARY outcome

Timeframe: 20-35 minutes following drug administration

Population: All participants that received sedation

We've used total power in the Beta range (13-30Hz) to evaluate change in firing pattern and oscillation frequency.

Outcome measures

Outcome measures
Measure	Dexmedetomidine Modulation of MER n=5 Participants Change in RMS value between baseline (awake) and maximal sedation during dexmedetomidine administration.
Change in Average Firing Pattern in the STN	39.9 percentage change Standard Error 76.2

SECONDARY outcome

Timeframe: 20-60 minutes after stopping drug administration

Population: All participants that received sedation.

The time it takes for the patient to become alert after drug administration is stopped.

Outcome measures

Outcome measures
Measure	Dexmedetomidine Modulation of MER n=5 Participants Change in RMS value between baseline (awake) and maximal sedation during dexmedetomidine administration.
Time to Recovery	16 minutes Standard Deviation 13

SECONDARY outcome

Timeframe: 30 minutes after stopping drug administration

Population: All participants that received sedation. As the activity did not return to baseline within the allocated time for the study (30 minutes), we report the portion of patients in which the activity returned to baseline within this time.

The portion of patients in which neuronal activity returned to baseline within 30 after stopping sedation.

Outcome measures

Outcome measures
Measure	Dexmedetomidine Modulation of MER n=5 Participants Change in RMS value between baseline (awake) and maximal sedation during dexmedetomidine administration.
Portion of Participants With Timely Return of the Neuronal Activity to Baseline	2 Participants

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Aeyal Raz

University od Wisconsin - Madison

Phone: 608-263-8100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place