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Clinical Trials/NCT02080286
NCT02080286
Unknown
Not Applicable

Boosting the Therapeutic Benefits of Prism Adaptation by Combining it With tDCS

University of Oxford1 site in 1 country40 target enrollmentFebruary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spatial Neglect
Sponsor
University of Oxford
Enrollment
40
Locations
1
Primary Endpoint
Behavioural Inattention Test (BIT)
Last Updated
8 years ago

Overview

Brief Summary

The present study aims to compare the relative therapeutic efficacy of prism adaptation therapy combined with real versus sham tDCS. The investigators will test the hypothesis that the magnitude and duration of neglect improvement will be increased when prism therapy is combined with real tDCS compared to sham tDCS.

A second objective is to test whether individual differences in baseline clinical or brain imaging measures can predict: 1) neglect severity or 2) inter-individual differences in patients' therapeutic response.

A third goal is to use brain imaging to characterize the patterns of neural change induced by the intervention to identify brain structures that mediate therapeutic response.

Detailed Description

'Neglect' is a common neurological syndrome that affects approximately 50% of right-hemisphere stroke patients. It is a complex multi-faceted syndrome, but its core defining feature is that patients lose the capacity to voluntarily control attention in the left half of space. Neglect has a significant debilitating effect on patients' functional independence and everyday life and indicates a poor prognosis for long-term functional recovery. To date, there is no effective rehabilitation intervention available for routine clinical use. One of the most promising experimental strategies for neglect rehabilitation is prism adaptation, a form of motor training that induces short-lived improvements in a variety of cognitive domains. However, its major limitation is that the benefits are transient. The investigators aim to test the hypothesis that by combining prism therapy with transcranial direct current stimulation (tDCS), this will boost learning/memory processes, resulting in larger and longer-lasting therapeutic effects. The investigators will conduct a randomized controlled clinical trial to test the efficacy of multi-session prism therapy combined with real versus sham tDCS for the rehabilitation of chronic post-stroke neglect. Baseline neuroimaging data will be used as predictor variables to explain inter-individual variation in therapeutic response. Contrasts between pre- and post-intervention imaging data will be performed to identify neural structures that mediate therapeutic effects.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
December 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18-85
  • At least one month post ischaemic or haemorrhagic stroke or brain damage to the right hemisphere
  • Diagnosis of neglect confirmed by evidence of neglect on at least one of the tests in the battery of neglect tests administered during the Recruitment Interview
  • Absolute contraindications to participation in any part of the study:
  • Anyone who does not have adequate understanding of English, sufficient to give informed consent
  • Limited verbal communication in the form of dysphasia
  • Any person who has a history of drug abuse as the data collected may be influenced by their condition
  • Any person who has a history of dementia or any other psychiatric illness as the data collected may be influenced by their condition
  • Absolute contraindications to participation in the tDCS part of the study:

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Behavioural Inattention Test (BIT)

Time Frame: Assessed at the recruitment interview (week 0) and at the exit interview (8 weeks after the intervention)

Change in score between the baseline session and the late post-intervention session.

Neglect Test Battery

Time Frame: Assessed at 2 separate pre-intervention baseline sessions at least 1 week apart. Re-assessed following the intervention at intervals of 1, 2, 4 and 8 weeks.

This battery features a range of computerized and paper-and-pencil tests of neglect (eg: cancellation, eye movement recordings, etc.). We are testing for the percentage change in performance on this battery from the baseline pre-intervention phase at each of the post-intervention timepoints.

Secondary Outcomes

  • Changes in brain imaging data(Change in a range of MRI measures between one baseline pre-intervention scan and the post-intervention scan (+ 5 weeks))

Study Sites (1)

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