Trial Outcomes & Findings for rTMS Therapy for Primary Orthostatic Tremor (NCT NCT02441985)

NCT ID: NCT02441985

Last Updated: 2025-04-02

Results Overview

The Fullerton Advanced Balance (FAB) Scale is a clinical assessment of balance ability and fall risk. Participants complete 10 physical activity challenges while observed, and their performance is rated on a 0-4 scale, where a higher score a greater ability to balance. Each item is then summed to generate a Total Score, ranging from 0-40, where a higher total score indicates greater overall balance and lower likelihood of fall risk. The reported measure is the change in the FAB Total Score from before and after, where a positive value implies improvement in balance, a negative value indicates a worsening of balance, and 0 indicates no change.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

Pre- to Post-Intervention, on average 3 hours

Results posted on

2025-04-02

Participant Flow

10/10 participants who expressed interest in research were randomized

Participant milestones

Participant milestones
Measure	Real rTMS Stimulation First, Then Sham rTMS Stimulation Participants received single 30 minute long session of real rTMS first that included 900 pulses delivered over the cerebellum, there was washout period of one day before they received sham rTMS dose of 900 pulses over the cerebellum	Sham rTMS Stimulation First, Then Real rTMS Stimulation Participants received single 30 minute long session of sham rTMS first that included 900 pulses delivered over the cerebellum, there was washout period of one day before they received real rTMS dose of 900 pulses over the cerebellum
First Intervention (30 Min) STARTED	5	5
First Intervention (30 Min) COMPLETED	5	5
First Intervention (30 Min) NOT COMPLETED	0	0
Washout (One Day) STARTED	5	5
Washout (One Day) COMPLETED	5	5
Washout (One Day) NOT COMPLETED	0	0
Second Intervention (30 Min) STARTED	5	5
Second Intervention (30 Min) COMPLETED	5	5
Second Intervention (30 Min) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

rTMS Therapy for Primary Orthostatic Tremor

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Pre- to Post-Intervention, on average 3 hours

Outcome measures

Outcome measures
Measure	Real rTMS Stimulation n=10 Participants Fullerton Advanced Balance (FAB) Scale: All participants will receive a clinical assessment of balance ability and fall risk.	Sham rTMS Stimulation n=10 Participants Fullerton Advanced Balance (FAB) Scale: All participants will receive a clinical assessment of balance ability and fall risk.
Change in Fullerton Advanced Balance (FAB) Scale Total Score After rTMS	2.8 change in score on a scale Standard Deviation 0.2	0.9 change in score on a scale Standard Deviation 0.01

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre- to Post-Intervention, on average 3 hours apart

Participants were asked to stand for as long as they could. Their standing duration was video recorded and timed in seconds. The measure reported is the change in standing time from before to after the rTMS intervention, where a positive value indicates an improvement in standing duration, a negative value indicates a worsening of standing duration, and 0 indicates no change.

Outcome measures

Outcome measures
Measure	Real rTMS Stimulation n=10 Participants Fullerton Advanced Balance (FAB) Scale: All participants will receive a clinical assessment of balance ability and fall risk.	Sham rTMS Stimulation n=10 Participants Fullerton Advanced Balance (FAB) Scale: All participants will receive a clinical assessment of balance ability and fall risk.
Standing Duration	126 seconds Standard Deviation 82.2	-6.7 seconds Standard Deviation 29.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre- to Post-Intervention

The TUG is a mobility test that is used to measure the basic mobility skills and gait speed of people who have neurological conditions. It includes a sit-to-stand component as well as walking 3 m, turning, and returning to the chair. People perform these tasks using regular footwear and customary walking aids. The measured outcome is the time in seconds to complete the entire sequence. For the outcome assessment the test will be videotaped and scored by a blind rater. We calculated the change between two time points (pre intervention value minus post intervention value)

Outcome measures

Outcome measures
Measure	Real rTMS Stimulation n=10 Participants Fullerton Advanced Balance (FAB) Scale: All participants will receive a clinical assessment of balance ability and fall risk.	Sham rTMS Stimulation n=10 Participants Fullerton Advanced Balance (FAB) Scale: All participants will receive a clinical assessment of balance ability and fall risk.
Timed "Up & Go" Test (TUG) Test	13 seconds Standard Deviation 1.5	12 seconds Standard Deviation 1.6

Adverse Events

Real rTMS Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham rTMS Stimulation

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

Aparna Wagle Shukla

University of Florida

Phone: 3522945400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Real rTMS Stimulation First, Then Sham rTMS Stimulation n=5 Participants Participants freceived 900 pulse of real rTMS	Sham rTMS Stimulation First, Then Real rTMS Stimulation n=5 Participants Participants received 900 pulse of sham rTMS	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Continuous	71.3 years STANDARD_DEVIATION 8.3 • n=5 Participants	71.3 years STANDARD_DEVIATION 8.3 • n=7 Participants	71.3 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Disease Duration	14.7 years STANDARD_DEVIATION 10.7 • n=5 Participants	14.7 years STANDARD_DEVIATION 10.7 • n=7 Participants	14.7 years STANDARD_DEVIATION 10.7 • n=5 Participants
Standing Duration	97 seconds STANDARD_DEVIATION 74 • n=5 Participants	97 seconds STANDARD_DEVIATION 74 • n=7 Participants	97 seconds STANDARD_DEVIATION 74 • n=5 Participants
Tremor Frequency	15.5 Hz STANDARD_DEVIATION 0.7 • n=5 Participants	15.5 Hz STANDARD_DEVIATION 0.7 • n=7 Participants	15.5 Hz STANDARD_DEVIATION 0.7 • n=5 Participants