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Transcranial Stimulation (tDCS) and Prism Adaptation in Spatial Neglect Rehabilitation

Primary Purpose

Spatial Neglect, Stroke, Cerebrovascular Disorders

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Prism Adaptation

Anodal tDCS

Sham tDCS

About this trial

This is an interventional treatment trial for Spatial Neglect focused on measuring spatial neglect, rehabilitation, brain stimulation, tDCS, prism adaptation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

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
Anyone with a metal implant or implantable device that is found to be unsafe or unknown for MRI following investigations by named researchers and staff radiographers would be excluded.
Pregnant women are excluded as a precaution as there are no data on the effect on maternal tDCS or MRI on the foetus

Potential contraindications to participation in the tDCS part of the study:

Participants on some prescription medications such as anti-depressants or pain medication may be excluded as they may be at an increased risk of seizure
Individuals who have a family history of epilepsy or seizure may be excluded as this may increase the individual's personal risk of susceptibility to seizures

Potential contraindications to participation in the MRI part of the study:

• An individual with a previous history of a surgical procedure may be excluded, depending on whether a metallic implant was used in their operation and whether the MRI-safety status of the implanted materials can be adequately assessed after requesting the medical/surgical notes (with patient consent) and/or post-surgical imaging and consulting with the staff radiographers who are legally responsible for determining participant safety in advance of any scanning.

Sites / Locations

FMRIB Centre, John Radcliffe Hospital, University of OxfordRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Prism adaptation + anodal tDCS

Prism Adaptation + Sham tDCS

Prism adaptation + no tDCS

Arm Description

Participants 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.

Participants 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.

Participants will receive no tDCS at all but will undergo a 20-minute session of prism adaptation. They will undergo 5 consecutive daily sessions.

Outcomes

Primary Outcome Measures

Behavioural Inattention Test (BIT)

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

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.

Secondary Outcome Measures

Changes in brain imaging data

We will test for changes in a range of MRI measures which we expect to be induced by the therapeutic intervention (measures of resting state and task functional MRI signal, grey and white matter, brain chemistry).

Full Information

NCT ID

NCT02080286

First Posted

March 4, 2014

Last Updated

October 10, 2017

Sponsor

University of Oxford

Collaborators

National Institute for Health Research, United Kingdom

1. Study Identification

Unique Protocol Identification Number

NCT02080286

Brief Title

Transcranial Stimulation (tDCS) and Prism Adaptation in Spatial Neglect Rehabilitation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Unknown status

Study Start Date

February 2014 (undefined)

Primary Completion Date

May 2018 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Oxford

Collaborators

National Institute for Health Research, United Kingdom

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spatial Neglect, Stroke, Cerebrovascular Disorders, Cerebral Infarction, Brain Diseases

Keywords

spatial neglect, rehabilitation, brain stimulation, tDCS, prism adaptation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prism adaptation + anodal tDCS

Arm Type

Active Comparator

Arm Description

Participants 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.

Arm Title

Prism Adaptation + Sham tDCS

Arm Type

Placebo Comparator

Arm Description

Participants 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.

Arm Title

Prism adaptation + no tDCS

Arm Type

Placebo Comparator

Arm Description

Participants will receive no tDCS at all but will undergo a 20-minute session of prism adaptation. They will undergo 5 consecutive daily sessions.

Intervention Type

Behavioral

Intervention Name(s)

Prism Adaptation

Intervention Description

All participants will undergo prism adaptation, a form of behavioural therapy involving reaching and pointing movements while wearing glasses that induce an optical shift.

Intervention Type

Device

Intervention Name(s)

Anodal tDCS

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sham tDCS

Intervention Description

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.

Primary Outcome Measure Information:

Title

Behavioural Inattention Test (BIT)

Description

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

Time Frame

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

Title

Neglect Test Battery

Description

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.

Secondary Outcome Measure Information:

Title

Changes in brain imaging data

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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: 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 Anyone with a metal implant or implantable device that is found to be unsafe or unknown for MRI following investigations by named researchers and staff radiographers would be excluded. Pregnant women are excluded as a precaution as there are no data on the effect on maternal tDCS or MRI on the foetus Potential contraindications to participation in the tDCS part of the study: Participants on some prescription medications such as anti-depressants or pain medication may be excluded as they may be at an increased risk of seizure Individuals who have a family history of epilepsy or seizure may be excluded as this may increase the individual's personal risk of susceptibility to seizures Potential contraindications to participation in the MRI part of the study: • An individual with a previous history of a surgical procedure may be excluded, depending on whether a metallic implant was used in their operation and whether the MRI-safety status of the implanted materials can be adequately assessed after requesting the medical/surgical notes (with patient consent) and/or post-surgical imaging and consulting with the staff radiographers who are legally responsible for determining participant safety in advance of any scanning.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jacinta O'Shea, PhD

Phone

+44 (0)1865 611455

jacinta.oshea@ndcn.ox.ac.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Thomas Smejka

Phone

+44 (0)1865 611461

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacinta O'Shea, Dr

Organizational Affiliation

University of Oxford

Official's Role

Principal Investigator

Facility Information:

Facility Name

FMRIB Centre, John Radcliffe Hospital, University of Oxford

City

Oxford

ZIP/Postal Code

OX3 9DU

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jacinta O'Shea, PhD

Phone

+44 (0)1865 611455

jacinta.oshea@ndcn.ox.ac.uk

First Name & Middle Initial & Last Name & Degree

Susan Field

Phone

+44 (0)1865 611450

12. IPD Sharing Statement

Citations:

PubMed Identifier

33175411

Citation

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.

Results Reference

derived

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Transcranial Stimulation (tDCS) and Prism Adaptation in Spatial Neglect Rehabilitation

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