Trial Outcomes & Findings for Study to Evaluate Treatment Effects Associated With the NeuroStar SoftStart Treatment Feature (NCT NCT05535062)

NCT ID: NCT05535062

Last Updated: 2025-02-17

Results Overview

The average Visual Analog Scale scores for the two conditions Dash protocol and modified DASH. VAS - Visual Analog Scale range is 0-100 (0- no pain/discomfort; 100- extreme discomfort/worse pain)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 10 days
• Results posted on: 2025-02-17

Participant Flow

Participant milestones

Measure	Modified DASH First Participants started with modified dash protocols first.	DASH Treatment First Participants started with DASH treatment first
Ramp up Phase (5 Days) STARTED	17	23
Ramp up Phase (5 Days) COMPLETED	17	23
Ramp up Phase (5 Days) NOT COMPLETED	0	0
Treatment Phase (4 Days) STARTED	17	23
Treatment Phase (4 Days) COMPLETED	17	23
Treatment Phase (4 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate Treatment Effects Associated With the NeuroStar SoftStart Treatment Feature

Baseline characteristics by cohort

Measure	All Subjects n=40 Participants Patients will be randomized after consent to receive modified Dash protocol with the New feature enabled repetitive Transcranial Magnetic Stimulation: the administration of a series of magnetic stimuli to the brain for the purpose of altering brain function
Age, Customized Mean Age	42 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Primary diagnosis	40 Participants n=5 Participants

PRIMARY outcome

Timeframe: 10 days

Population: VAS scores were collected for both standard and modified dash conditions for each participant. An average VAS score for each condition was calculated for each participant.

The average Visual Analog Scale scores for the two conditions Dash protocol and modified DASH.

VAS - Visual Analog Scale range is 0-100 (0- no pain/discomfort; 100- extreme discomfort/worse pain)

Outcome measures

Measure	Modified DASH n=40 Participants All participants receiving Modified DASH condition	DASH n=40 Participants All participants receiving DASH condition
Evaluate Comfort of TMS Treatment	29.9 VAS score on a scale Standard Deviation 18.4	29.3 VAS score on a scale Standard Deviation 18.0

SECONDARY outcome

Timeframe: 5 days

Population: Average time in number of days to reach maximum treatment intensity (120% MT). During the ramp-up phase, this could take 1-5 days in both arm.

Th average time to reach the prescribed treatment intensity. Once TMS therapy begins, adjustments to the stimulation intensity can begin immediately, as needed, according to subject tolerance. The TMS treater will assess if the subject can tolerate escalating the treatment MT by 10% at different time points. At each interval and the end of treatment, the treater will record the current intensity (%MT) achieved. The goal will be to reach and sustain the target intensity established by the treating physician (120%MT).

Outcome measures

Measure	Modified DASH n=23 Participants All participants receiving Modified DASH condition	DASH n=17 Participants All participants receiving DASH condition
Time to Reach Prescribed Treatment Intensity	1.78 days Standard Deviation 1.28	1.9 days Standard Deviation 1.05

Adverse Events

Dash Protocol

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Modified Dash Protocol With the New Feature Enabled

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Dash Protocol n=40 participants at risk Patients will be randomized after consent to receive standard Dash protocol repetitive Transcranial Magnetic Stimulation: the administration of a series of magnetic stimuli to the brain for the purpose of altering brain function	Modified Dash Protocol With the New Feature Enabled n=40 participants at risk Patients will be randomized after consent to receive modified Dash protocol with the New feature enabled repetitive Transcranial Magnetic Stimulation: the administration of a series of magnetic stimuli to the brain for the purpose of altering brain function
Skin and subcutaneous tissue disorders Eye Discomfort	2.5% 1/40 • Number of events 1 • up to 9 days for each subject. 1st day of treatment to last day of treatment Standard adverse event definition	0.00% 0/40 • up to 9 days for each subject. 1st day of treatment to last day of treatment Standard adverse event definition
Musculoskeletal and connective tissue disorders Hand Movement	7.5% 3/40 • Number of events 6 • up to 9 days for each subject. 1st day of treatment to last day of treatment Standard adverse event definition	7.5% 3/40 • Number of events 4 • up to 9 days for each subject. 1st day of treatment to last day of treatment Standard adverse event definition
Skin and subcutaneous tissue disorders Discomfort	0.00% 0/40 • up to 9 days for each subject. 1st day of treatment to last day of treatment Standard adverse event definition	2.5% 1/40 • Number of events 1 • up to 9 days for each subject. 1st day of treatment to last day of treatment Standard adverse event definition

Additional Information

Neha Goyal

Neuronetics

Phone: 763-528-1599

Email: neha.goyal@neurostar.com

Results disclosure agreements

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