Efficacy of methylphenidate and Attention Process Training in traumatic brain injury rehabilitatio

Phase 4

• Conditions: Traumatic Brain Injury (TBI); Injuries and Accidents - Other injuries and accidents; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Neurological - Other neurological disorders

• Registration Number: ACTRN12612000484842
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Traumatic brain injury:
Moderate to severe traumatic brain injury within the preceding 12 months and demonstrated attentional impairment.

Healthy controls:
Recruited from the general population.

Exclusion Criteria

Traumatic Brain Injury:
Inadequate English, physical abilities or cognitive abilities to complete the tasks or training, past history of treatment for drug or alcohol dependence, previous neurological history, treatment with medications for which methylphenidate is contraindicated, or current medical conditions for which methylphenidate is contraindicated.

Healthy controls:
Inadequate English, physical abilities or cognitive abilities to complete the tasks, a history of neurological or psychiatric trauma or illness, a history of treatment for attentional difficulties or disorders including Attention Deficit Hyperactivity Disorder.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance on standard cognitive measures (Paced Auditory Serial Addition Test, Symbol Digit Modalities Test, Ruff 2&7 Selective Attention Test, N-back, Computerised Selective Attention Task).[Week 1, week 8 (on drug), week 9 (drug free), and 6-month follow-up.];Performance on The Rating Scale of Attentional Behaviour as rated by a treating therapist and significant other.[Week 1, week 8 (on drug), week 9 (drug free), and 6-month follow-up.];Functional outcome performance as measured with responses of the TBI patient, a significant other, and a treating therapist on The Mayo-Portland Adaptability Inventory.[Week 1 and 6-month follow-up.]

Secondary Outcome Measures

Name	Time	Method
Side effects as measured on a modified version of the Moss Rehabilitation Research Institute Side Effects Monitoring Form, and blood pressure and heart rate measurements.<br><br>Previous studies suggest that side effects are not likely to occur frequently or severely. It is unlikely that participants will experience significant discomfort or harm from participating in this study, however possible side effects may include decreased appetite, nervousness, insomnia, irritability, headache, drowsiness, dizziness, increased heart rate and/or blood pressure, dry mouth, nausea or rash. Participants may have none, some or all of these effects.[Weekly for 7 weeks.]