Last reviewed · How we verify
NCT04578743: ExACTT
Exercise as Concussion Therapy Trial- 2
Phase 2 trial testing Graded Exercise Therapy: ClearPlay(TM) in Mild Traumatic Brain Injury. Withdrawn.
30 September 2021
Quick facts
| Lead sponsor | ANSwers Neuroscience, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 October 2020 |
| Primary completion | 30 September 2021 |
| Estimated completion | 30 September 2021 |
| Sites | 3 locations across Australia |
Drugs / interventions tested
- Graded Exercise Therapy: ClearPlay(TM)
Conditions studied
- Mild Traumatic Brain Injury — all drugs for Mild Traumatic Brain Injury →
- Concussion, Mild — all drugs for Concussion, Mild →
Sponsor
ANSwers Neuroscience, Inc.
Who can join
Adults 14 to 45, any sex, with Mild Traumatic Brain Injury or Concussion, Mild. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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. 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".
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Traumatic brain injury and immunological outcomes: the double-edged killer.
Datta S, Lin F, Jones LD, Pingle SC, et al · · 2023 · cited 10× · PMID 37228857 · DOI 10.2144/fsoa-2023-0037 -
Trends of Decentralized Clinical Trials Using Digital Technology for Decentralization
Sato T, Mizumoto S, Ota M, Shikano M. · · 2022 · DOI 10.2139/ssrn.4243284
Verify or expand the search:
- PubMed search for NCT04578743
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Mild Traumatic Brain Injury
Currently open trials in the same condition.
- NCT07246993 — Targeting Neuroplasticity for Persistent Post-Concussive Cognitive Symptoms · NA · recruiting
- NCT07356167 — Passive Neurosensory Reintegration Training as a Tool to Augment Mild Traumatic Brain Injury · NA · recruiting
- NCT07097792 — Concussion Recovery and Support Program · NA · recruiting
- NCT06956417 — REhabilitation of MEMory Symptoms After BRain Concussion · NA · recruiting
- NCT06217575 — Brain Research Assessing Impacts of Neurophysiological Processing Speed Training in Veterans · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04578743 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by ANSwers Neuroscience, Inc.
- Last refreshed: 3 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04578743.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing