Transcranial Stimulation (tDCS) and Prism Adaptation in Spatial Neglect Rehabilitation
Boosting the Therapeutic Benefits of Prism Adaptation by Combining it With tDCS
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 4, 2014
CompletedFirst Posted
Study publicly available on registry
March 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedOctober 11, 2017
October 1, 2017
4.2 years
March 4, 2014
October 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Behavioural Inattention Test (BIT)
Change in score between the baseline session and the late post-intervention session.
Assessed at the recruitment interview (week 0) and at the exit interview (8 weeks after the intervention)
Neglect Test Battery
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.
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.
Secondary Outcomes (1)
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 Arms (3)
Prism adaptation + anodal tDCS
ACTIVE COMPARATORParticipants will receive 1 milliamp (mA) anodal tDCS over the left primary motor cortex concurrent with a 20-minute session of prism adaptation. They will undergo 5 consecutive daily sessions.
Prism Adaptation + Sham tDCS
PLACEBO COMPARATORParticipants will receive Sham tDCS over the left primary motor cortex concurrent with a 20-minute session of prism adaptation. They will undergo 5 consecutive daily sessions.
Prism adaptation + no tDCS
PLACEBO COMPARATORParticipants will receive no tDCS at all but will undergo a 20-minute session of prism adaptation. They will undergo 5 consecutive daily sessions.
Interventions
All participants will undergo prism adaptation, a form of behavioural therapy involving reaching and pointing movements while wearing glasses that induce an optical shift.
Participants will receive 1mA anodal tDCS over the left primary motor cortex. The active (positive) electrode will be centered on the scalp overlying the primary motor cortex and the reference (negative) electrode will be placed over the contralateral supraorbital ridge. The stimulation will last 20 minutes and run concurrent with the duration of the prism adaptation therapy.
Participants will receive 1mA sham tDCS over the left primary motor cortex. The active (positive) electrode will be centered on the scalp overlying the primary motor cortex and the reference (negative) electrode will be placed over the contralateral supraorbital ridge. The stimulation will last 20 minutes and run concurrent with the duration of the prism adaptation therapy.
Eligibility Criteria
You may qualify if:
- 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:
- Anyone who has a previous personal history of epilepsy, seizures, febrile convulsions as a child or recurrent fainting fits will be excluded from the tDCS part of the study
- Any metallic implant in the neck, head, or eye that is situated within the path of the tDCS current, and anyone with any implanted electrical devices, would be excluded as there is a risk of heating with tDCS
- Pregnant women are excluded as a precaution as there are no data on the effect on maternal tDCS or MRI on the foetus
- Absolute contraindications to participation in the MRI part of the study:
- People who suffer from claustrophobia will be excluded from the MRI part of the study if they state they are unable to tolerate the scanner environment
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
FMRIB Centre, John Radcliffe Hospital, University of Oxford
Oxford, OX3 9DU, United Kingdom
Related Publications (1)
Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
PMID: 33175411DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacinta O'Shea, Dr
University of Oxford
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2014
First Posted
March 6, 2014
Study Start
February 1, 2014
Primary Completion
May 1, 2018
Study Completion
December 1, 2019
Last Updated
October 11, 2017
Record last verified: 2017-10