Back to resultsStudy to Evaluate Treatment Effects Associated With the NeuroStar SoftStart Treatment Feature (Comfort Start)
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
repetitive Transcranial Magnetic Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring TMS, Major Depressive Disorder, NeuroStar TMS
Eligibility Criteria
Inclusion Criteria:
- 1. 22-70 years.
2. Subject qualifies to receive TMS Therapy with the NeuroStar Advanced Therapy System to treat Major Depressive Disorder (MDD) per current FDA-cleared treatment guidelines as evaluated by the treating physician.
3. Subject has MDD diagnosis according to applicable DSM-IV, DSM-IV-TR, DSM-V, ICD-9, or ICD-10 criteria.
4. Subject failed to respond to at least one prior anti-depressant medication. 5. Subject consented to receive TMS Therapy to treat MDD with his or her physician independent of potential participation in this clinical study.
6. Subject must agree not to take analgesic pain medication(s) prior to TMS therapy sessions.
7. Subject provides written consent to take part in the study.
Exclusion Criteria:
1. Subject satisfies any one or more of the contraindications for TMS Therapy per current treatment guidelines as determined by the PI.
2. Physician intends to treat the subject with an off-label TMS Therapy or indication.
3. Family history of seizures or epilepsy. 4. Subject has received prior TMS. 5. Subject is currently taking analgesic medication or substances which may affect their perception or sensation of pain.
6. Known or suspected pregnancy.
Sites / Locations
- TMS of South Tampa
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Dash Protocol
Modified Dash protocol with the New feature enabled
Arm Description
Patients will be randomized after consent to receive standard Dash protocol
Patients will be randomized after consent to receive modified Dash protocol with the New feature enabled
Outcomes
Primary Outcome Measures
Evaluate comfort of TMS treatment
The difference in the change in Visual Analog Scale scores for Comfort after rTMS stimulation between treatments administered with the Dash protocol and with New feature enabled. Comfort will be evaluated as a change for all observations between groups, observations from Baseline to end of escalation phase, observations between groups during the crossover phase and observations within a patient between treatments in the cross-over phase.
At minute 3:45, and at the end of the treatment session, the subject will be asked to complete a Visual Analog Scale (VAS), for Comfort/Pain.
Secondary Outcome Measures
Ability to reach prescribed treatment intensity
The ability to reach the prescribed treatment intensity, the time it takes to reach the prescribed intensity, maximum treatment intensity reached, subject treatment preference and discontinuations due to treatment discomfort between the two treatment protocols. Once TMS therapy begins, adjustments to lower the stimulation intensity can begin immediately, as needed, for subject tolerance. The 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 %MT achieved. The goal will be to reach and sustain the target MT established by the treating physician of 120%MT. Once the target MT has been achieved and sustained for a certain period of time recording and increases of %MT may be discontinued, but re-started at central intervals if %MT is subsequently reduced.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05535062
Brief Title
Study to Evaluate Treatment Effects Associated With the NeuroStar SoftStart Treatment Feature
Acronym
Comfort Start
Official Title
A Prospective, Randomized, Single Blind, Crossover Study to Evaluate Treatment Effects Associated With the NeuroStar New Treatment Feature
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
June 20, 2023 (Actual)
Study Completion Date
August 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuronetics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the comfort of the NeuroStar® Advanced Therapy System regular prescribed TMS protocol versus a New Feature.
Detailed Description
This is a 2 week study to evaluate the New Feature an exclusive feature available on the NeuroStar® Advanced Therapy System. This feature introduces a series of stepped pulses within each pulse train ramping up the pulse magnitude to the prescribed treatment level. Patients will be randomized after consent to receive either the standard Dash protocol or the modified Dash protocol with the New feature enabled. The subjects will be switched between treatment protocols and asked to complete comfort, and depression questionnaires.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
TMS, Major Depressive Disorder, NeuroStar TMS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Patients will be switched between different treatment arms and asked to complete questionnaires.
Masking
Participant
Masking Description
The study will be randomized to avoid any bias in treatment arm assignment. Subjects will be blinded to the actual treatment arm throughout the study to allow patient to provide an honest assessment of the treatment they are receiving daily. Subjects will not be informed of the treatment at the end of their study participation.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dash Protocol
Arm Type
Active Comparator
Arm Description
Patients will be randomized after consent to receive standard Dash protocol
Arm Title
Modified Dash protocol with the New feature enabled
Arm Type
Active Comparator
Arm Description
Patients will be randomized after consent to receive modified Dash protocol with the New feature enabled
Intervention Type
Device
Intervention Name(s)
repetitive Transcranial Magnetic Stimulation
Intervention Description
the administration of a series of magnetic stimuli to the brain for the purpose of altering brain function
Primary Outcome Measure Information:
Title
Evaluate comfort of TMS treatment
Description
The difference in the change in Visual Analog Scale scores for Comfort after rTMS stimulation between treatments administered with the Dash protocol and with New feature enabled. Comfort will be evaluated as a change for all observations between groups, observations from Baseline to end of escalation phase, observations between groups during the crossover phase and observations within a patient between treatments in the cross-over phase.
At minute 3:45, and at the end of the treatment session, the subject will be asked to complete a Visual Analog Scale (VAS), for Comfort/Pain.
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Ability to reach prescribed treatment intensity
Description
The ability to reach the prescribed treatment intensity, the time it takes to reach the prescribed intensity, maximum treatment intensity reached, subject treatment preference and discontinuations due to treatment discomfort between the two treatment protocols. Once TMS therapy begins, adjustments to lower the stimulation intensity can begin immediately, as needed, for subject tolerance. The 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 %MT achieved. The goal will be to reach and sustain the target MT established by the treating physician of 120%MT. Once the target MT has been achieved and sustained for a certain period of time recording and increases of %MT may be discontinued, but re-started at central intervals if %MT is subsequently reduced.
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. 22-70 years.
2. Subject qualifies to receive TMS Therapy with the NeuroStar Advanced Therapy System to treat Major Depressive Disorder (MDD) per current FDA-cleared treatment guidelines as evaluated by the treating physician.
3. Subject has MDD diagnosis according to applicable DSM-IV, DSM-IV-TR, DSM-V, ICD-9, or ICD-10 criteria.
4. Subject failed to respond to at least one prior anti-depressant medication. 5. Subject consented to receive TMS Therapy to treat MDD with his or her physician independent of potential participation in this clinical study.
6. Subject must agree not to take analgesic pain medication(s) within 8 hours prior to TMS therapy sessions.
7. Subject provides written consent to take part in the study.
Exclusion Criteria:
1. Subject satisfies any one or more of the contraindications for TMS Therapy per current treatment guidelines as determined by the PI.
2. Physician intends to treat the subject with an off-label TMS Therapy or indication.
3. Family history of seizures or epilepsy. 4. Subject has received prior TMS. 5. Subject is currently taking analgesic medication or substances which may affect their perception or sensation of pain.
6. Known or suspected pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve A Erickson, BS
Organizational Affiliation
Neuronetics
Official's Role
Study Director
Facility Information:
Facility Name
TMS of South Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate Treatment Effects Associated With the NeuroStar SoftStart Treatment Feature
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