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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04578743




Registration number
NCT04578743
Ethics application status
Date submitted
1/10/2020
Date registered
8/10/2020
Date last updated
8/10/2020

Titles & IDs
Public title
Exercise as Concussion Therapy Trial- 2
Scientific title
Exercise as Concussion Therapy Trial
Secondary ID [1] 0 0
ExACTT-2
Universal Trial Number (UTN)
Trial acronym
ExACTT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Traumatic Brain Injury 0 0
Concussion, Mild 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Graded Exercise Therapy: ClearPlay(TM)

Experimental: Graded Exercise - 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.

Experimental: Passive Stretching - 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.


Treatment: Devices: 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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
2 Years

Eligibility
Key inclusion criteria
1. 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;

2. Subject is fluent in English, able to understand and agree to comply with protocol
requirements, and complete all assessments;

3. 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.

4. Subject has daily access to the internet.
Minimum age
14 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of prior head injury as defined by:

1. An injury/blow to the head within 12 months prior to screening with any
associated residual symptoms;

2. An injury/blow to the head within 3 months prior to screening diagnosed as a
concussion;

3. 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;

2. Evidence of blood or micro-hemorrhages on prior or current computed tomography scan or
magnetic resonance imaging scan if obtained;

3. Diagnosis of a neurological condition including the following: stroke, multiple
sclerosis, epilepsy, brain tumor/cancer, encephalitis, dementia, movement disorder, or
spontaneous nystagmus;

4. Psychiatric history with any of the following:

1. History of psychiatric hospitalization, history of legal trouble for violence;

2. 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;

3. Prior diagnosis of psychotic disorder, bipolar disorder, eating disorder,
substance abuse disorder;

5. Current use of a beta blocker;

6. History of drug or alcohol dependency or abuse within a year before Screening, by
self-report;

7. Two or more the following cardiovascular risk factors:

1. Prior diagnosis of, or currently taking medication for cardiovascular, metabolic
or pulmonary conditions;

2. Family history of myocardial infarction, coronary revascularization or sudden
death before 55 years;

3. Diagnosis of hypertension;

4. Diagnosis of hyperlipidemia;

5. Subjects with peripheral circulatory disorders;

8. Subjects who are unable or unwilling to exercise for health or personal reasons;

9. Subjects who have musculoskeletal injuries which could make exercise difficult or
painful.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
University of Queensland - Brisbane
Recruitment hospital [3] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4101 - Brisbane
Recruitment postcode(s) [3] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ANSwers Neuroscience, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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:

1. ClearHeart©, ANSwers Neuroscience Pty Ltd commercial prototype for cold pressor testing,
compared to ice bucket testing.

2. ClearPlay©, ANSwers Neuroscience Pty Ltd commercial prototype based on the joint
position error test to assess "whiplash".
Trial website
https://clinicaltrials.gov/show/NCT04578743
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christina Master, MD
Address 0 0
Children's Hospital of Philadelphia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Barry Kosofsky, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
+1 914 8743611
Fax 0 0
Email 0 0
bkosofskymd@gmail.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04578743