Pain, IntractableNCT04727216

Intermittent vs. Continuous Dorsal Root Ganglion Stimulation

A study testing Dorsal Root Ganglion Stimulation (DRG-S) in people with Pain, Intractable and Pain, Chronic, run by Spine and Pain Institute of New York at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate and compare the therapeutic efficacy of intermittent Dorsal Root Ganglion Stimulation (DRG-S) to standard continuous stimulation in patients with chronic intractable pain Read more about this study

Who is it for?: Ages 21 to 75 years
Conditions the study is for: Pain, Intractable, Pain, Chronic
What is being tested?: Dorsal Root Ganglion Stimulation (DRG-S)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 23 Mar 2021to 15 Sep 2021
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is able to provide informed consent to participate in the study;
Subject is 21 years of age or older;
Subject has been treated with DRG-S permanent implant device (Abbott, Plano, TX, USA) for a minimum of 3 months with sustained pain relief >50% for chronic intractable pain;
Subject's DRG-S parameters have remained unchanged for at least 30 days prior to the beginning of the study

Who cannot join

Subject had a recent change in pain medication regimen resulting in increase in Morphine Milligram Equivalent dosing within 60 days prior to the beginning of the study
Subject received an additional pain interventional procedure within 60 days prior to the beginning of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Spine and Pain Institute NY
New York, New York, 10065

Other trials in United States

About this study

Official title: Intermittent Dorsal Root Ganglion Stimulation Dosing Comparison to Standard Continuous Dosing in Treating Chronic Pain

Read the detailed description

Intermittent Dorsal Root Ganglion Stimulation (DRG-S) dosing consists of preprogrammed cycles during which stimulation is delivered with standard DRG-S parameters alternated with periods during which no stimulation is being delivered.

In this study the investigators propose to evaluate therapeutic efficacy of Intermittent DRG-S at 1 minute on: 1 minute off and 1 minute on: 2 minute off dosing in comparison to standard continuous DRG-S dosing and determine if there is noninferiority between the intermittent and continuous paradigms in chronic pain patients with permanent DRG-S implants.

Conditions: Pain, Intractable, Pain, Chronic
Being tested: Dorsal Root Ganglion Stimulation (DRG-S)
Keywords: Dorsal Root Ganglion Stimulation, Intermittent Stimulation Dosing
Medical subject headings: Pain, Intractable, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dorsal Root Ganglion Stimulation (DRG-S)Device
Dorsal Root Ganglion stimulation will be delivered with continuous dosing and 2 different ON/OFF periods to compare effects for each patient.

Study groups in NCT04727216
Study group	Role	What they receive
Continuous DRG-S Dosing	Active comparator	2 week stimulation program using continuous DRG-S dosing at standard stimulation parameters Receives: Device: Dorsal Root Ganglion Stimulation (DRG-S)
1 minute on: 1 minute off Intermittent DRG-S Dosing	Experimental	2 week stimulation program using 1 minute on: 1 minute off intermittent DRG-S dosing at standard stimulation parameters Receives: Device: Dorsal Root Ganglion Stimulation (DRG-S)
1 minute on: 2 minutes off Intermittent DRG-S Dosing	Experimental	2 week stimulation program using 1 minute on: 2 minutes off intermittent DRG-S dosing at standard stimulation parameters Receives: Device: Dorsal Root Ganglion Stimulation (DRG-S)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Numerical Rating Scale (NRS) Pain Scores Between Continuous and 1:1 Intermittent Dosing
Pain Questionnaire - (Scale is 0 to 10 with 0 being no pain and 10 being worst pain imaginable)
Measured: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:1 intermittent dosing
Change in Numerical Rating Scale (NRS) Pain Scores Between Continuous and 1:2 Intermittent Dosing
Pain Questionnaire - (Scale is 0 to 10 with 0 being no pain and 10 being worst pain imaginable)
Measured: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:2 intermittent dosing

Secondary outcomes (4)

Change in Quality of Life Between Continuous and 1:1 Intermittent Dosing
Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)
Measured: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:1 intermittent dosing
Change in Quality of Life Between Continuous and 1:2 Intermittent Dosing
Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)
Measured: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:2 intermittent dosing
Change in Disability Index Between Continuous and 1:1 Intermittent Dosing
Questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Measured: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:1 intermittent dosing
Change in Disability Index Between Continuous and 1:2 Intermittent Dosing
Questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Measured: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:2 intermittent dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Mar 202115 Sep 2021

First posted27 Jan 2021
Study start23 Mar 2021
Primary completion1 Aug 2021
Study completion15 Sep 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Pain, IntractableStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Subjects will undergo 3 sequential 2-week dosing stimulation programs \[1.) continuous, 2.) 1 minute on: 1 minute off, and 3.) 1 minute on: 2 minutes\] in randomized order and double blinded fashion for a total of 6 consecutive weeks.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04727216
Sponsor's protocol ID: Intermittent DRG-S Dosing
Status last verified: Sep 2021
First submitted: 22 Jan 2021
Last updated: 22 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Deer TR, Levy RM, Kramer J, Poree L, Amirdelfan K, Grigsby E, Staats P, Burton AW, Burgher AH, Obray J, Scowcroft J, Golovac S, Kapural L, Paicius R, Kim C, Pope J, Yearwood T, Samuel S, McRoberts WP, Cassim H, Netherton M, Miller N, Schaufele M, Tavel E, Davis T, Davis K, Johnson L, Mekhail N. Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial. Pain. 2017 Apr;158(4):669-681. doi: 10.1097/j.pain.0000000000000814.
PubMed 28030470
Miller JP, Eldabe S, Buchser E, Johanek LM, Guan Y, Linderoth B. Parameters of Spinal Cord Stimulation and Their Role in Electrical Charge Delivery: A Review. Neuromodulation. 2016 Jun;19(4):373-84. doi: 10.1111/ner.12438. Epub 2016 May 6.
PubMed 27150431
Chapman KB, Yousef TA, Foster A, D Stanton-Hicks M, van Helmond N. Mechanisms for the Clinical Utility of Low-Frequency Stimulation in Neuromodulation of the Dorsal Root Ganglion. Neuromodulation. 2021 Jun;24(4):738-745. doi: 10.1111/ner.13323. Epub 2020 Nov 25.
PubMed 33236811
Chapman KB, Yousef TA, Vissers KC, van Helmond N, D Stanton-Hicks M. Very Low Frequencies Maintain Pain Relief From Dorsal Root Ganglion Stimulation: An Evaluation of Dorsal Root Ganglion Neurostimulation Frequency Tapering. Neuromodulation. 2021 Jun;24(4):746-752. doi: 10.1111/ner.13322. Epub 2020 Nov 23.
PubMed 33227827
Esposito MF, Malayil R, Hanes M, Deer T. Unique Characteristics of the Dorsal Root Ganglion as a Target for Neuromodulation. Pain Med. 2019 Jun 1;20(Suppl 1):S23-S30. doi: 10.1093/pm/pnz012.
PubMed 31152179
Koopmeiners AS, Mueller S, Kramer J, Hogan QH. Effect of electrical field stimulation on dorsal root ganglion neuronal function. Neuromodulation. 2013 Jul-Aug;16(4):304-11; discussion 310-1. doi: 10.1111/ner.12028. Epub 2013 Feb 19.
PubMed 23421796
Arcourt A, Gorham L, Dhandapani R, Prato V, Taberner FJ, Wende H, Gangadharan V, Birchmeier C, Heppenstall PA, Lechner SG. Touch Receptor-Derived Sensory Information Alleviates Acute Pain Signaling and Fine-Tunes Nociceptive Reflex Coordination. Neuron. 2017 Jan 4;93(1):179-193. doi: 10.1016/j.neuron.2016.11.027. Epub 2016 Dec 15.
PubMed 27989460
Koetsier E, Franken G, Debets J, van Kuijk SMJ, Linderoth B, Joosten EA, Maino P. Dorsal Root Ganglion Stimulation in Experimental Painful Diabetic Polyneuropathy: Delayed Wash-Out of Pain Relief After Low-Frequency (1Hz) Stimulation. Neuromodulation. 2020 Feb;23(2):177-184. doi: 10.1111/ner.13048. Epub 2019 Sep 16.
PubMed 31524325
Vesper J, Slotty P, Schu S, Poeggel-Kraemer K, Littges H, Van Looy P, Agnesi F, Venkatesan L, Van Havenbergh T. Burst SCS Microdosing Is as Efficacious as Standard Burst SCS in Treating Chronic Back and Leg Pain: Results From a Randomized Controlled Trial. Neuromodulation. 2019 Feb;22(2):190-193. doi: 10.1111/ner.12883. Epub 2018 Nov 19.
PubMed 30456795
Deer TR, Patterson DG, Baksh J, Pope JE, Mehta P, Raza A, Agnesi F, Chakravarthy KV. Novel Intermittent Dosing Burst Paradigm in Spinal Cord Stimulation. Neuromodulation. 2021 Apr;24(3):566-573. doi: 10.1111/ner.13143. Epub 2020 Mar 23.
PubMed 32202044

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1/2
Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain
Intractable Pain, Palliative Care
RecruitingPhase 1
Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer
Intractable Pain, Palliative Care
RecruitingObservational study
Dexmedetomidine for Refractory Pain in Palliative Cancer Patients
Cancer, Palliative Care, Patient Care
Not yet recruiting
Transcutaneous Genital Nerves Stimulation for the Treatment of Refractory Chronic Pelvic and Genital Pain in Women.
Refractory Visceral Pelvic Pain, Refractory Genital Pain
Active, not recruitingObservational study
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Angina Pectoris, Angina Pectoris, Stable

All Pain, Intractable trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intermittent Dorsal Root Ganglion Stimulation Dosing Comparison to Standard Continuous Dosing in Treating Chronic Pain
ClinicalTrials.gov ID: NCT04727216
Acronym / sponsor ID: Intermittent DRG-S Dosing
Conditions: Pain, Intractable, Pain, Chronic
Keywords: Dorsal Root Ganglion Stimulation, Intermittent Stimulation Dosing
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 15 participants (actual)
Lead sponsor: Spine and Pain Institute of New YorkUniversity, hospital or other
Study start: 23 Mar 2021 (actual)
Primary completion: 1 Aug 2021 (actual)
Study completion: 15 Sep 2021 (estimated)
First posted: 27 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: Subjects will undergo 3 sequential 2-week dosing stimulation programs [1.) continuous, 2.) 1 minute on: 1 minute off, and 3.) 1 minute on: 2 minutes] in randomized order and double blinded fashion for a total of 6 consecutive weeks.

Arm	Type	Receives
Continuous DRG-S Dosing	Active comparator	Device: Dorsal Root Ganglion Stimulation (DRG-S)2 week stimulation program using continuous DRG-S dosing at standard stimulation parameters
1 minute on: 1 minute off Intermittent DRG-S Dosing	Experimental	Device: Dorsal Root Ganglion Stimulation (DRG-S)2 week stimulation program using 1 minute on: 1 minute off intermittent DRG-S dosing at standard stimulation parameters
1 minute on: 2 minutes off Intermittent DRG-S Dosing	Experimental	Device: Dorsal Root Ganglion Stimulation (DRG-S)2 week stimulation program using 1 minute on: 2 minutes off intermittent DRG-S dosing at standard stimulation parameters

Who may qualify

Ages: 21 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subject is able to provide informed consent to participate in the study;
Subject is 21 years of age or older;
Subject has been treated with DRG-S permanent implant device (Abbott, Plano, TX, USA) for a minimum of 3 months with sustained pain relief >50% for chronic intractable pain;
Subject's DRG-S parameters have remained unchanged for at least 30 days prior to the beginning of the study

Key exclusion criteria (2 listed)

Subject had a recent change in pain medication regimen resulting in increase in Morphine Milligram Equivalent dosing within 60 days prior to the beginning of the study
Subject received an additional pain interventional procedure within 60 days prior to the beginning of the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dorsal Root Ganglion Stimulation (DRG-S)Dorsal Root Ganglion stimulation will be delivered with continuous dosing and 2 different ON/OFF periods to compare effects for each patient.	Device	1 minute on: 1 minute off Intermittent DRG-S Dosing, 1 minute on: 2 minutes off Intermittent DRG-S Dosing, Continuous DRG-S Dosing

Primary outcome

Change in Numerical Rating Scale (NRS) Pain Scores Between Continuous and 1:1 Intermittent Dosing
Time frame: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:1 intermittent dosing
Pain Questionnaire - (Scale is 0 to 10 with 0 being no pain and 10 being worst pain imaginable)
Change in Numerical Rating Scale (NRS) Pain Scores Between Continuous and 1:2 Intermittent Dosing
Time frame: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:2 intermittent dosing
Pain Questionnaire - (Scale is 0 to 10 with 0 being no pain and 10 being worst pain imaginable)

4 secondary outcomes

Change in Quality of Life Between Continuous and 1:1 Intermittent Dosing
Time frame: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:1 intermittent dosing
Change in Quality of Life Between Continuous and 1:2 Intermittent Dosing
Time frame: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:2 intermittent dosing
Change in Disability Index Between Continuous and 1:1 Intermittent Dosing
Time frame: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:1 intermittent dosing
Change in Disability Index Between Continuous and 1:2 Intermittent Dosing
Time frame: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:2 intermittent dosing

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
Background: PubMed 28030470Deer TR, Levy RM, Kramer J, Poree L, Amirdelfan K, Grigsby E, Staats P, Burton AW, Burgher AH, Obray J, Scowcroft J, Golovac S, Kapural L, Paicius R, Kim C, Pope J, Yearwood T, Samuel S, McRoberts WP, Cassim H, Netherton M, Miller N, Schaufele M, Tavel E, Davis T, Davis K, Johnson L, Mekhail N. Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial. Pain. 2017 Apr;158(4):669-681. doi: 10.1097/j.pain.0000000000000814.
Background: PubMed 27150431Miller JP, Eldabe S, Buchser E, Johanek LM, Guan Y, Linderoth B. Parameters of Spinal Cord Stimulation and Their Role in Electrical Charge Delivery: A Review. Neuromodulation. 2016 Jun;19(4):373-84. doi: 10.1111/ner.12438. Epub 2016 May 6.
Background: PubMed 33236811Chapman KB, Yousef TA, Foster A, D Stanton-Hicks M, van Helmond N. Mechanisms for the Clinical Utility of Low-Frequency Stimulation in Neuromodulation of the Dorsal Root Ganglion. Neuromodulation. 2021 Jun;24(4):738-745. doi: 10.1111/ner.13323. Epub 2020 Nov 25.
Background: PubMed 33227827Chapman KB, Yousef TA, Vissers KC, van Helmond N, D Stanton-Hicks M. Very Low Frequencies Maintain Pain Relief From Dorsal Root Ganglion Stimulation: An Evaluation of Dorsal Root Ganglion Neurostimulation Frequency Tapering. Neuromodulation. 2021 Jun;24(4):746-752. doi: 10.1111/ner.13322. Epub 2020 Nov 23.
Background: PubMed 31152179Esposito MF, Malayil R, Hanes M, Deer T. Unique Characteristics of the Dorsal Root Ganglion as a Target for Neuromodulation. Pain Med. 2019 Jun 1;20(Suppl 1):S23-S30. doi: 10.1093/pm/pnz012.
Background: PubMed 23421796Koopmeiners AS, Mueller S, Kramer J, Hogan QH. Effect of electrical field stimulation on dorsal root ganglion neuronal function. Neuromodulation. 2013 Jul-Aug;16(4):304-11; discussion 310-1. doi: 10.1111/ner.12028. Epub 2013 Feb 19.
Background: PubMed 27989460Arcourt A, Gorham L, Dhandapani R, Prato V, Taberner FJ, Wende H, Gangadharan V, Birchmeier C, Heppenstall PA, Lechner SG. Touch Receptor-Derived Sensory Information Alleviates Acute Pain Signaling and Fine-Tunes Nociceptive Reflex Coordination. Neuron. 2017 Jan 4;93(1):179-193. doi: 10.1016/j.neuron.2016.11.027. Epub 2016 Dec 15.
Background: PubMed 31524325Koetsier E, Franken G, Debets J, van Kuijk SMJ, Linderoth B, Joosten EA, Maino P. Dorsal Root Ganglion Stimulation in Experimental Painful Diabetic Polyneuropathy: Delayed Wash-Out of Pain Relief After Low-Frequency (1Hz) Stimulation. Neuromodulation. 2020 Feb;23(2):177-184. doi: 10.1111/ner.13048. Epub 2019 Sep 16.
Background: PubMed 30456795Vesper J, Slotty P, Schu S, Poeggel-Kraemer K, Littges H, Van Looy P, Agnesi F, Venkatesan L, Van Havenbergh T. Burst SCS Microdosing Is as Efficacious as Standard Burst SCS in Treating Chronic Back and Leg Pain: Results From a Randomized Controlled Trial. Neuromodulation. 2019 Feb;22(2):190-193. doi: 10.1111/ner.12883. Epub 2018 Nov 19.
Background: PubMed 32202044Deer TR, Patterson DG, Baksh J, Pope JE, Mehta P, Raza A, Agnesi F, Chakravarthy KV. Novel Intermittent Dosing Burst Paradigm in Spinal Cord Stimulation. Neuromodulation. 2021 Apr;24(3):566-573. doi: 10.1111/ner.13143. Epub 2020 Mar 23.
Individual participant dataSharing planned: No

Related trials for Pain, Intractable

Not yet recruitingPhase 1/2
Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain
Intractable Pain, Palliative Care
RecruitingPhase 1
Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer
Intractable Pain, Palliative Care
RecruitingObservational study
Dexmedetomidine for Refractory Pain in Palliative Cancer Patients
Cancer, Palliative Care, Patient Care
Not yet recruiting
Transcutaneous Genital Nerves Stimulation for the Treatment of Refractory Chronic Pelvic and Genital Pain in Women.
Refractory Visceral Pelvic Pain, Refractory Genital Pain
Active, not recruitingObservational study
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Angina Pectoris, Angina Pectoris, Stable

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dorsal Root Ganglion Stimulation (DRG-S) in people with Pain, Intractable and Pain, Chronic, run by Spine and Pain Institute of New York at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Numerical Rating Scale (NRS) Pain Scores Between Continuous and 1:1 Intermittent Dosing (time frame: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:1 intermittent dosing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04727216, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.