Trial Outcomes & Findings for Functional Imaging of Tremor Circuits and Mechanisms of Treatment Response (NCT NCT02495883)

Results Overview

Regions that were differentially activated in ET as measured by number of statistically significant voxels (cluster size). This represents the number of activated voxels seen in the ET group that were not present in the Healthy Control group.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

56 participants

Primary outcome timeframe

At visit 1 or 2 based on randomization table.

Results posted on

2020-12-02

Participant Flow

Participant milestones

Participant milestones
Measure	Essential Tremor Group 50ml of 40% ethanol will be administered to participants diagnosed with Essential Tremor. Propranolol SR 60-120mg will be administered daily to participants over an estimated period of two weeks. Ethanol: 50ml of 40% Ethanol Propranolol: Beta blocker	Health Volunteer Group Healthy Volunteers
Overall Study STARTED	32	24
Overall Study COMPLETED	31	24
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Essential Tremor Group 50ml of 40% ethanol will be administered to participants diagnosed with Essential Tremor. Propranolol SR 60-120mg will be administered daily to participants over an estimated period of two weeks. Ethanol: 50ml of 40% Ethanol Propranolol: Beta blocker	Health Volunteer Group Healthy Volunteers
Overall Study Excessive head motion	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Essential Tremor Group n=31 Participants 50ml of 40% ethanol will be administered to participants diagnosed with Essential Tremor. Propranolol SR 60-120mg will be administered daily to participants over an estimated period of two weeks. Ethanol: 50ml of 40% Ethanol Propranolol: Beta blocker	Health Volunteer Group n=24 Participants Healthy Volunteers	Total n=55 Participants Total of all reporting groups
Age, Continuous	63.5 years STANDARD_DEVIATION 15.4 • n=31 Participants	60.5 years STANDARD_DEVIATION 11.5 • n=24 Participants	62.2 years STANDARD_DEVIATION 13.7 • n=55 Participants
Sex: Female, Male Female	14 Participants n=31 Participants	16 Participants n=24 Participants	30 Participants n=55 Participants
Sex: Female, Male Male	17 Participants n=31 Participants	8 Participants n=24 Participants	25 Participants n=55 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Montreal Cognitive Assessment	27.9 units on a scale STANDARD_DEVIATION 1.7 • n=31 Participants	28.1 units on a scale STANDARD_DEVIATION 1.6 • n=24 Participants	28.0 units on a scale STANDARD_DEVIATION 1.7 • n=55 Participants
Tremor Research Group Essential Tremor Rating Scale (TETRAS)	37.8 units on a scale STANDARD_DEVIATION 19.0 • n=31 Participants	NA units on a scale STANDARD_DEVIATION NA • n=24 Participants	37.8 units on a scale STANDARD_DEVIATION 19.0 • n=55 Participants

PRIMARY outcome

Timeframe: At visit 1 or 2 based on randomization table.

Population: The methodology of this trial utilizes functional MRI measures. In order to understand the significance of a group's unique brain responses, the data between the two groups (Essential Tremor vs. Healthy Controls) are statistically compared to derive regions that are unique. The output of the analyses show regions that are unique to ET. NOTE: Data structure cannot be provided separately for each group based on the experiment paradigm and analysis methods.

Regions that were differentially activated in ET as measured by number of statistically significant voxels (cluster size). This represents the number of activated voxels seen in the ET group that were not present in the Healthy Control group.

Outcome measures

Outcome measures
Measure	All Subjects n=55 Participants All subject data
Regions With fMRI Differences Between ET and Controls Right Cerebellum	139 Number of Activated Voxels
Regions With fMRI Differences Between ET and Controls Left Putamen	93 Number of Activated Voxels
Regions With fMRI Differences Between ET and Controls Right Posterior Cingulate/Thalamus	85 Number of Activated Voxels
Regions With fMRI Differences Between ET and Controls Right Sensorimotor Cortex	74 Number of Activated Voxels

Adverse Events

ET Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Volunteers

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

Fatta Nahab, MD

UCSD

Phone: 858-822-5871

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place