Exercise as Concussion Therapy Trial- 2 (ExACTT)

ANSwers Neuroscience

Status and phase: Withdrawn; Phase 2

Conditions: Mild Traumatic Brain Injury; Concussion, Mild

Treatments: Device: Graded Exercise Therapy: ClearPlay(TM)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04578743

ExACTT-2

Details and patient eligibility

About

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".

Full 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

Sex: All

Ages: 14 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Graded Exercise

Experimental group

Description:

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.

Treatment:

Device: Graded Exercise Therapy: ClearPlay(TM)

Passive Stretching

Experimental group

Description:

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:

Device: Graded Exercise Therapy: ClearPlay(TM)