Exercise as Concussion Therapy Trial- 2

NCT04578743 | Withdrawn Phase 2 FDA Device

• 1 other identifier: ExACTT-2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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

Conditions

Mild Traumatic Brain Injury; Concussion, Mild

Keywords

Concussion; Mild Traumatic Brain Injury (mTBI); Exercise Therapy; Telemedicine; Therapeutic Intervention; Autonomic Function; Medical Device

Outcome Measures

Primary Outcomes (1)

• 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.

  2 Years

Study Arms (2)

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.

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.

Device: Graded Exercise Therapy: ClearPlay(TM)

Interventions

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.

Graded Exercise; Passive Stretching

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• ANSwers Neuroscience, Inc.: lead

Study Sites (3)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

University of Queensland

Brisbane, Queensland, 4101, Australia

Location

Alfred Health

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Christina Master, MD

  Children's Hospital of Philadelphia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 8, 2020
• Study Start: October 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: March 3, 2022

Record last verified: 2022-02

Locations

AU (3)