Trial Outcomes & Findings for rTMS in Spasmodic Dysphonia (NCT NCT02957942)

NCT ID: NCT02957942

Last Updated: 2020-10-01

Results Overview

Count of participants who experience and adverse response to rTMS treatment.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 2.5 hours
• Results posted on: 2020-10-01

Participant Flow

Participant milestones

Measure	Spasmodic Dysphonia 1Hz repetitive transcranial magnetic stimulation (rTMS) 1Hz repetitive transcranial magnetic stimulation (rTMS): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)	Healthy Control Healthy adults 1Hz repetitive transcranial magnetic stimulation (rTMS) 1Hz repetitive transcranial magnetic stimulation (rTMS): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)
Overall Study STARTED	7	13
Overall Study COMPLETED	7	6
Overall Study NOT COMPLETED	0	7

Reasons for withdrawal

Measure	Spasmodic Dysphonia 1Hz repetitive transcranial magnetic stimulation (rTMS) 1Hz repetitive transcranial magnetic stimulation (rTMS): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)	Healthy Control Healthy adults 1Hz repetitive transcranial magnetic stimulation (rTMS) 1Hz repetitive transcranial magnetic stimulation (rTMS): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)
Overall Study Withdrawal by Subject	0	1
Overall Study Practicing experiment protocol	0	6

Baseline Characteristics

rTMS in Spasmodic Dysphonia

Baseline characteristics by cohort

Measure	Spasmodic Dysphonia n=7 Participants 1Hz repetitive transcranial magnetic stimulation (rTMS) 1Hz repetitive transcranial magnetic stimulation (rTMS): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)	Healthy Control n=6 Participants Healthy adults 1Hz repetitive transcranial magnetic stimulation (rTMS) 1Hz repetitive transcranial magnetic stimulation (rTMS): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)	Total n=13 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	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	61 years STANDARD_DEVIATION 3.8 • n=5 Participants	53.2 years STANDARD_DEVIATION 6.6 • n=7 Participants	57.4 years STANDARD_DEVIATION 6.4 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 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	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	5 Participants n=7 Participants	12 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
Region of Enrollment United States	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 2.5 hours

Count of participants who experience and adverse response to rTMS treatment.

Outcome measures

Measure	Spasmodic Dysphonia n=7 Participants 1Hz repetitive transcranial magnetic stimulation (rTMS) 1Hz repetitive transcranial magnetic stimulation (rTMS): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)	Healthy Control n=6 Participants Healthy adults 1Hz repetitive transcranial magnetic stimulation (rTMS) 1Hz repetitive transcranial magnetic stimulation (rTMS): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)
Adverse Response to rTMS	0 Participants	0 Participants

PRIMARY outcome

Timeframe: baseline and 2.5 hours

The change from baseline in CSP duration will be reported. The CSP is an interruption of voluntary muscle contraction after single pulse transcranial stimulation. The duration of the period of silent muscle activity will be measured to test the effects of rTMS intervention. There is no known clinical relevance for this outcome measure.

Outcome measures

Measure	Spasmodic Dysphonia n=7 Participants 1Hz repetitive transcranial magnetic stimulation (rTMS) 1Hz repetitive transcranial magnetic stimulation (rTMS): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)	Healthy Control n=6 Participants Healthy adults 1Hz repetitive transcranial magnetic stimulation (rTMS) 1Hz repetitive transcranial magnetic stimulation (rTMS): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)
Change in Duration of Cortical Silent Period (CSP)	-2.4 milliseconds Standard Deviation 10.6	3.6 milliseconds Standard Deviation 8.8

SECONDARY outcome

Timeframe: baseline and 2.5 hours

Changes from baseline in the number of voice breaks during speech will be reported. Voice breaks will be measured by asking subjects to repeat 10 sentences. The frequency of voice breaks in the recorded 10 sentences will be counted.

Outcome measures

Measure	Spasmodic Dysphonia n=7 Participants 1Hz repetitive transcranial magnetic stimulation (rTMS) 1Hz repetitive transcranial magnetic stimulation (rTMS): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)	Healthy Control n=6 Participants Healthy adults 1Hz repetitive transcranial magnetic stimulation (rTMS) 1Hz repetitive transcranial magnetic stimulation (rTMS): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)
Change in Number of Voice Breaks	-1.3 total voice breaks Standard Deviation 4.7	0 total voice breaks Standard Deviation 0

SECONDARY outcome

Timeframe: baseline and 2.5 hours

CAPE-V (overall severity) testing before and after rTMS consisted of the repetition of six sentences and two sustained vowels (/a/;/i/). A short sample of spontaneous speech (approximately 60s) was also collected for qualitative analysis of voice. The CAPE-V ratings were completed by three assessors who were blinded to group and pre/post-test. The assessors listened to the voice recordings for each participant and rated them for all six parameters listed above from 0 to 100, with higher values indicating worse severity. Ratings for each voice parameter were then averaged across the three assessors. We chose to analyze the change in the CAPE-V parameter for "Overall Severity" to represent an overall assessment of voice quality from pre- to post-rTMS (Post Score - Pre Score) as it had the greatest likelihood of detecting any small changes that may be perceived.

Outcome measures

Measure	Spasmodic Dysphonia n=7 Participants 1Hz repetitive transcranial magnetic stimulation (rTMS) 1Hz repetitive transcranial magnetic stimulation (rTMS): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)	Healthy Control n=6 Participants Healthy adults 1Hz repetitive transcranial magnetic stimulation (rTMS) 1Hz repetitive transcranial magnetic stimulation (rTMS): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)
Change in Voice Quality (Overall Severity) With the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)	-3.7 score on a scale Standard Deviation 10.5	0.9 score on a scale Standard Deviation 5.2

SECONDARY outcome

Timeframe: baseline and 2.5 hours

Quantitative assessment of voice quality was completed with acoustic analysis of each participant's production of the ten sentences from the Spasmodic Dysphonia Attribute Inventory (SDAI). A custom script in Praat (Boersma & Weenink, 2018) was used to calculate cepstral peak prominence smoothed (CPPS) for each sentence production. CPPS is a relatively new measure that reflects vocal fold periodicity and noise components in the vocal spectrum. CPPS has been found to be correlated with perceived severity of voice symptoms and higher CPPS values represent a more normal vocal quality. CPPS values (in dB) were averaged across the ten sentences of the SDAI to derive an average CPPS for each participant before and after rTMS. Change for each participant was calculated as the average CPPS at post-rTMS minus average CPPS at pre-rTMS. The values for each group were then averaged to report the average change in CPPS for Controls and Spasmodic Dysphonia.

Outcome measures

Measure	Spasmodic Dysphonia n=7 Participants 1Hz repetitive transcranial magnetic stimulation (rTMS) 1Hz repetitive transcranial magnetic stimulation (rTMS): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)	Healthy Control n=6 Participants Healthy adults 1Hz repetitive transcranial magnetic stimulation (rTMS) 1Hz repetitive transcranial magnetic stimulation (rTMS): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)
Change in Cepstral Peak Prominence Smoothed (CPPS)	0.1 dB Standard Deviation 0.7	0.3 dB Standard Deviation 0.8

Adverse Events

Spasmodic Dysphonia

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Healthy Control

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Spasmodic Dysphonia n=7 participants at risk 1Hz repetitive transcranial magnetic stimulation (rTMS) 1Hz repetitive transcranial magnetic stimulation (rTMS): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)	Healthy Control n=6 participants at risk Healthy adults 1Hz repetitive transcranial magnetic stimulation (rTMS) 1Hz repetitive transcranial magnetic stimulation (rTMS): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)
Respiratory, thoracic and mediastinal disorders Throat Pain	42.9% 3/7 • Number of events 3 • 1 day	83.3% 5/6 • Number of events 5 • 1 day
Injury, poisoning and procedural complications Tenderness on Skin Area of Insertion	42.9% 3/7 • Number of events 3 • 1 day	83.3% 5/6 • Number of events 5 • 1 day
General disorders Neck Pain	14.3% 1/7 • Number of events 1 • 1 day	66.7% 4/6 • Number of events 4 • 1 day
General disorders Dental Pain/Discomfort	0.00% 0/7 • 1 day	16.7% 1/6 • Number of events 1 • 1 day
General disorders Dizziness	0.00% 0/7 • 1 day	16.7% 1/6 • Number of events 1 • 1 day
General disorders Other(fatigue)	14.3% 1/7 • Number of events 1 • 1 day	0.00% 0/6 • 1 day

Additional Information

Mo Chen

University of Minnesota

Phone: 612-624-5220

Email: mchen@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place