Methylphenidate in Adults with Severe Traumatic brain injury for the Enhancement of Recovery (MASTER)

Phase 4

• Conditions: Traumatic brain injury; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12615001044516
• Lead Sponsor: Royal Rehab

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

A participant is identified to be eligible if they are aged between 18-65yo, have a new traumatic brain injury within the past 6 months, a measurable PTA of greater than 7 days.
All participants need to be able to give informed consent.

Exclusion Criteria

Non-English speaking
Dysphasia
Current treatment with psycho-active medications
cardiac events
hypertension
abnormal ECG
tics
post-traumatic seizures
pregnancy (negative bhCG)
prior history of alcohol or drug abuse
Any medications which are contra-indicated with MPD: monoamine oxidase inhibitors, clonidine, dopamine agonists or antagonists, certain anaesthetics

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Attention, assessed by Paced Auditory Serial Addition Test (PASAT)<br>[Day 1, day 5, day 12, day 19, day 96];Attention, assessed by Digit Span Test (DST)[Days 1,5,12,19,96];Working memory, assessed by Symbol Digit Modality Test (SDMT)[Days 1,5,12,19,96]

Secondary Outcome Measures

Name	Time	Method
Quality of life as assessed by World Health Organisation Quality of Life-Bref (WHOQOL-Bref).<br><br>[Day 96];Review of hospital records to assess length of inpatient stay<br>[From date of enrolment to day 96 of participation];Side effects as measured by side effect questionnaire which has been designed specifically for this study<br>[From date of enrolment to days 12,19,96 of participation];Hospital Anxiety and Depression Scale[From date of enrolment to days 1,5,12,19,96];Mayo-Portland Adaptability Inventory-4 (MPAI-4)[From date of enrolment to day 96 of participation ]