Trial Outcomes & Findings for Electrophysiological Study of the Effects of Limb Cooling on Essential Tremor (NCT NCT01093027)

Results Overview

Average tremor amplitude during the Outstretched, Abducted, Nose, and Mug conditions of the Tremor Rating Scale test.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

After 10 minutes of limb cooling treatment.

Results posted on

2012-12-19

Participant Flow

Visits were scheduled between June 2010 and December 2011.

Participant milestones

Participant milestones
Measure	15 - 30 The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.	30 - 15 The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
Visit 1 STARTED	10	10
Visit 1 COMPLETED	10	10
Visit 1 NOT COMPLETED	0	0
Visit 2 STARTED	10	10
Visit 2 COMPLETED	10	10
Visit 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Electrophysiological Study of the Effects of Limb Cooling on Essential Tremor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	15 - 30 n=10 Participants The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.	30 - 15 n=10 Participants The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.	Total n=20 Participants Total of all reporting groups
Age Continuous	71.2 years STANDARD_DEVIATION 6.8 • n=93 Participants	76.3 years STANDARD_DEVIATION 4.9 • n=4 Participants	73.8 years STANDARD_DEVIATION 6.3 • n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	5 Participants n=4 Participants	9 Participants n=27 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	5 Participants n=4 Participants	11 Participants n=27 Participants

PRIMARY outcome

Timeframe: After 10 minutes of limb cooling treatment.

Average tremor amplitude during the Outstretched, Abducted, Nose, and Mug conditions of the Tremor Rating Scale test.

Outcome measures

Outcome measures
Measure	15 - 30 n=10 Participants The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.	30 - 15 n=10 Participants The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
Tremor Amplitude Visit 1	127 cm/s^2 Standard Deviation 50	104 cm/s^2 Standard Deviation 44
Tremor Amplitude Visit 2	150 cm/s^2 Standard Deviation 73	100 cm/s^2 Standard Deviation 58

SECONDARY outcome

Timeframe: After 10 minutes of limb cooling treatment.

Arm tremor severity was rated on a scale from 0=None to 4=Severe during each of four conditions: arm outstretched, hand close to mouth and arm abducted, performing a finger to nose maneuver, and holding a mug. The Tremor Rating Scale score was the mean of the scores for the four conditions, and ranged from a score of 0=None to 4=Severe.

Outcome measures

Outcome measures
Measure	15 - 30 n=10 Participants The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.	30 - 15 n=10 Participants The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
Tremor Rating Scale Visit 2	1.68 units on a scale Standard Deviation 0.65	1.32 units on a scale Standard Deviation 0.47
Tremor Rating Scale Visit 1	1.35 units on a scale Standard Deviation 0.61	1.65 units on a scale Standard Deviation 0.49

Adverse Events

15 - 30

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

30 - 15

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

Virgilio Evidente MD

Mayo Clinic

Phone: 480-301-8000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place