Mild Traumatic Brain InjuryPhase 2ExACTTNCT04578743

Exercise as Concussion Therapy Trial- 2

A Phase 2 study testing Graded Exercise Therapy: ClearPlay(TM) in people with Mild Traumatic Brain Injury and Concussion, Mild, run by ANSwers Neuroscience, Inc. at 3 sites in Australia.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 14 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Mild Traumatic Brain Injury, Concussion, Mild
What is being tested?: Graded Exercise Therapy: ClearPlay(TM)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 3 sitesAustralia
Study dates: 1 Oct 2020to 30 Sep 2021
Phase: Phase 2
Are there results?: None posted in the registry

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 14 to 45 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Male or female subjects aged ≥14 to ≤45, able and willing to provide informed consent (≥18 years), or informed consent is obtained by the parent or legal guardian for minor subjects, with the minor providing age appropriate assent, according to local law and regulations;
Subject is fluent in English, able to understand and agree to comply with protocol requirements, and complete all assessments;
Subject has a history of recent concussion as diagnosed by a health care professional within 3 to 14 days of enrolment; Note: Concussion is defined as a head injury/blow to the head resulting in any of the following 3 signs and/or new symptoms: (1) amnesia for less than 24 hours; (2) Loss of consciousness for less than 30 minutes; (3) Glasgow Coma Scale score > = 13; (4) Dazed and Confused/bell rung; with at least 1 new symptom or augmentation of a previous symptom on the PCSS as compared with baseline at the time of enrolment, including: headaches, dizziness, fatigue, irritability, insomnia, difficulty concentrating, and/or memory difficulties; (5) The composite symptom score on the PCSS must be at least 3 points higher post-concussion than pre-concussion.
Subject has daily access to the internet.

Who cannot join

History of prior head injury as defined by:
An injury/blow to the head within 12 months prior to screening with any associated residual symptoms;
An injury/blow to the head within 3 months prior to screening diagnosed as a concussion;
An injury/blow to the head within 3 months prior to screening with any of the following symptoms: amnesia, loss of consciousness, dazed and confused/bell rung;
Evidence of blood or micro-hemorrhages on prior or current computed tomography scan or magnetic resonance imaging scan if obtained;
Diagnosis of a neurological condition including the following: stroke, multiple sclerosis, epilepsy, brain tumor/cancer, encephalitis, dementia, movement disorder, or spontaneous nystagmus;

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Psychiatric history with any of the following:
History of psychiatric hospitalization, history of legal trouble for violence;
Requires psychotropic medication other than (1) stable dose of a selective serotonin reuptake inhibitors (SSRI) medication, or (2) stable dose of a tricyclic antidepressants (TCA) medication;
Prior diagnosis of psychotic disorder, bipolar disorder, eating disorder, substance abuse disorder;
Current use of a beta blocker;
History of drug or alcohol dependency or abuse within a year before Screening, by self-report;
Two or more the following cardiovascular risk factors:
Prior diagnosis of, or currently taking medication for cardiovascular, metabolic or pulmonary conditions;
Family history of myocardial infarction, coronary revascularization or sudden death before 55 years;
Diagnosis of hypertension;
Diagnosis of hyperlipidemia;
Subjects with peripheral circulatory disorders;
Subjects who are unable or unwilling to exercise for health or personal reasons;
Subjects who have musculoskeletal injuries which could make exercise difficult or painful.

Trial locations and contacts

3 sites in 1 country.

Australia3 sites

University of Queensland
Brisbane, Queensland, 4101
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Alfred Health
Melbourne, Victoria, 3004

Other trials in Australia

About this study

Official title: Exercise as Concussion Therapy Trial

This study is a Phase 2, open-label study of a therapeutic intervention (graded exercise)compared to a reference therapy (passive stretching) in patients who have sustained mTBI. Subjects will be randomly assigned with a ratio of 1:1 to complete either graded exercise or passive stretching using a parallel-group design.

The effects of graded exercise and passive stretching will be compared using ClearPlay© (ANSwers Neuroscience Pty Ltd commercial mobile application)

The study will also validate the performance of two devices:

ClearHeart©, ANSwers Neuroscience Pty Ltd commercial prototype for cold pressor testing, compared to ice bucket testing.
ClearPlay©, ANSwers Neuroscience Pty Ltd commercial prototype based on the joint position error test to assess "whiplash".

Read the detailed description

Study Type: Interventional Estimated Enrollment: 400 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Therapeutic Intervention, Open-Label Study to Compare the Efficacy and Safety of Graded Exercise Compared to Passive Stretching in Subjects Who Have Sustained a Mild Traumatic Brain Injury Estimated Study Start Date: October 1, 2020 Estimated Primary Completion Date: September 30, 2022 Estimated Study Completion Date: September 30, 2023

Conditions: Mild Traumatic Brain Injury, Concussion, Mild
Being tested: Graded Exercise Therapy: ClearPlay(TM)
Keywords: Concussion, Mild Traumatic Brain Injury (mTBI), Exercise Therapy, Telemedicine, Therapeutic Intervention, Autonomic Function, Medical Device
Medical subject headings: Brain Concussion

What participants receive

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

Graded Exercise Therapy: ClearPlay(TM)Device
ClearPlayTM; a novel therapeutic intervention, downloadable to an Apple i-touch or i-phone device, that provides a telemetry-based graded exercise program that enables remote monitoring of symptoms.

Study groups in NCT04578743
Study group	Role	What they receive
Graded Exercise	Experimental	ClearPlay(TM): a novel therapeutic intervention, downloadable to an Apple i-touch or i-phone device, will provide a telemetry-based graded exercise program for 20 minutes each day, identifying a heart rate target that will be advanced weekly for up to 8 weeks as symptoms resolve. Receives: Device: Graded Exercise Therapy: ClearPlay(TM)
Passive Stretching	Experimental	ClearPlay(TM): we have created a passive stretching program (placebo arm) downloadable to an Apple i-touch or i-phone device, that will provide a telemetry-based guided passive stretching program for 20 minutes each day for up to 8 weeks as symptoms resolve. Receives: Device: Graded Exercise Therapy: ClearPlay(TM)

What is being measured

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

ExACTT
The primary objective of the study is to compare the effects of graded exercise and passive stretching using ClearPlayTM (ANSwers Neuroscience Pty Ltd commercial mobile application) on recovery following mTBI in the Australian setting.
Measured: 2 Years

Timeline

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

1 Oct 202030 Sep 2021

First posted8 Oct 2020
Study start1 Oct 2020
Primary completion30 Sep 2021
Study completion30 Sep 2021

Why it stopped: COVID-induced lockdowns.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Mild Traumatic Brain InjuryStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This study is a Phase 2, open-label study of a therapeutic intervention (graded exercise) compared to a reference therapy (passive stretching) in patients who have sustained mTBI. Subjects will be randomly assigned with a ratio of 1:1 to complete either graded exercise or passive stretching using a parallel-group design.
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04578743
Sponsor's protocol ID: ExACTT-2
Acronym: ExACTT
Status last verified: Feb 2022
First submitted: 1 Oct 2020
Last updated: 3 Mar 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

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

RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
Traumatic Brain Injury, Post-Concussion Syndrome
Recruiting
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Post-Concussion Syndrome, COVID Long-Haul
Not yet recruiting
Sleep MAPP in the Polytrauma/TBI System of Care
Insomnia Disorder, Mild Traumatic Brain Injury
Recruiting
EXercise-induced PhysioLogical Adaptations In Neurological Disorders
Epilepsy, Functional Neurological Disorder

All Mild Traumatic Brain Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exercise as Concussion Therapy Trial
ClinicalTrials.gov ID: NCT04578743
Acronym / sponsor ID: ExACTT / ExACTT-2
Conditions: Mild Traumatic Brain Injury, Concussion, Mild
Keywords: Concussion, Mild Traumatic Brain Injury (mTBI), Exercise Therapy, Telemedicine, Therapeutic Intervention, Autonomic Function, Medical Device
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: COVID-induced lockdowns.
Enrolment: 0 participants (actual)
Lead sponsor: ANSwers Neuroscience, Inc.Industry (pharma, biotech, devices)
Study start: 1 Oct 2020 (actual)
Primary completion: 30 Sep 2021 (actual)
Study completion: 30 Sep 2021 (actual)
First posted: 8 Oct 2020 (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.

The effects of graded exercise and passive stretching will be compared using ClearPlay© (ANSwers Neuroscience Pty Ltd commercial mobile application)

The study will also validate the performance of two devices:

ClearHeart©, ANSwers Neuroscience Pty Ltd commercial prototype for cold pressor testing, compared to ice bucket testing.
ClearPlay©, ANSwers Neuroscience Pty Ltd commercial prototype based on the joint position error test to assess "whiplash".

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This study is a Phase 2, open-label study of a therapeutic intervention (graded exercise) compared to a reference therapy (passive stretching) in patients who have sustained mTBI. Subjects will be randomly assigned with a ratio of 1:1 to complete either graded exercise or passive stretching using a parallel-group design.

Arm	Type	Receives
Graded Exercise	Experimental	Device: Graded Exercise Therapy: ClearPlay(TM)ClearPlay(TM): a novel therapeutic intervention, downloadable to an Apple i-touch or i-phone device, will provide a telemetry-based graded exercise program for 20 minutes each day, identifying a heart rate target that will be advanced weekly for up to 8 weeks as symptoms resolve.
Passive Stretching	Experimental	Device: Graded Exercise Therapy: ClearPlay(TM)ClearPlay(TM): we have created a passive stretching program (placebo arm) downloadable to an Apple i-touch or i-phone device, that will provide a telemetry-based guided passive stretching program for 20 minutes each day for up to 8 weeks as symptoms resolve.

Who may qualify

Ages: 14 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

Male or female subjects aged ≥14 to ≤45, able and willing to provide informed consent (≥18 years), or informed consent is obtained by the parent or legal guardian for minor subjects, with the minor providing age appropriate assent, according to local law and regulations;
Subject is fluent in English, able to understand and agree to comply with protocol requirements, and complete all assessments;
Subject has a history of recent concussion as diagnosed by a health care professional within 3 to 14 days of enrolment; Note: Concussion is defined as a head injury/blow to the head resulting in any of the following 3 signs and/or new symptoms: (1) amnesia for less than 24 hours; (2) Loss of consciousness for less than 30 minutes; (3) Glasgow Coma Scale score > = 13; (4) Dazed and Confused/bell rung; with at least 1 new symptom or augmentation of a previous symptom on the PCSS as compared with baseline at the time of enrolment, including: headaches, dizziness, fatigue, irritability, insomnia, difficulty concentrating, and/or memory difficulties; (5) The composite symptom score on the PCSS must be at least 3 points higher post-concussion than pre-concussion.
Subject has daily access to the internet.

Key exclusion criteria (20 listed)

History of prior head injury as defined by:
Evidence of blood or micro-hemorrhages on prior or current computed tomography scan or magnetic resonance imaging scan if obtained;
Diagnosis of a neurological condition including the following: stroke, multiple sclerosis, epilepsy, brain tumor/cancer, encephalitis, dementia, movement disorder, or spontaneous nystagmus;
Psychiatric history with any of the following:
Current use of a beta blocker;

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
Graded Exercise Therapy: ClearPlay(TM)ClearPlayTM; a novel therapeutic intervention, downloadable to an Apple i-touch or i-phone device, that provides a telemetry-based graded exercise program that enables remote monitoring of symptoms.	Device	Graded Exercise, Passive Stretching

Primary outcome

ExACTT
Time frame: 2 Years
The primary objective of the study is to compare the effects of graded exercise and passive stretching using ClearPlayTM (ANSwers Neuroscience Pty Ltd commercial mobile application) on recovery following mTBI in the Australian setting.

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.

Related trials for Mild Traumatic Brain Injury

RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
Traumatic Brain Injury, Post-Concussion Syndrome
Recruiting
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Post-Concussion Syndrome, COVID Long-Haul
Not yet recruiting
Sleep MAPP in the Polytrauma/TBI System of Care
Insomnia Disorder, Mild Traumatic Brain Injury
Recruiting
EXercise-induced PhysioLogical Adaptations In Neurological Disorders
Epilepsy, Functional Neurological Disorder

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.

Christina Master, MD study director

Children's Hospital of Philadelphia

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Graded Exercise Therapy: ClearPlay(TM) in people with Mild Traumatic Brain Injury and Concussion, Mild, run by ANSwers Neuroscience, Inc. at 3 sites in Australia.

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 20 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: withdrawn, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Australia. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

ExACTT (time frame: 2 Years). 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 NCT04578743.

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 3 Mar 2022.