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| Name | Class |
|---|---|
| University of Glasgow | OTHER |
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After a stroke affecting the right side of the brain, many patients are affected by "spatial neglect": the damage to the brain causes them to ignore the left side of their surroundings. At its most extreme they may be unaware that they have a left side, or believe that it is moving normally when it is in fact paralysed. In milder cases, people may be unable to recognise touch on the left side if their right side is also being touched, or objects in their left visual field if something is visible to their right. Neglect alters peoples' quality of life profoundly, often renders them more dependent on others to undertake basic activities of daily living, and makes effective rehabilitation much more difficult.
The limited success of current treatment approaches indicates gaps in understanding of the underlying mechanisms of neglect and its recovery. Recent data suggest that the problems in responding to the left side are a result of an imbalance of activity in those parts of the brain responsible for deciding which side to pay attention to. It might therefore be possible to help people with neglect by "rebalancing" the brain either by increasing activity in the damaged side, or alternatively by reducing activity in the undamaged side. In this pilot study, the investigators will test whether they can help by doing the second of these things.
The investigators propose to conduct a pilot clinical trial to explore whether using electric currents to temporarily modify the activity of specific areas of the intact side of the brain, influences recovery from neglect, when used either alone, or in combination with a training method that has previously appeared promising as a treatment. Brain activity will be modified using a technique called "transcranial direct current stimulation (tDCS)", in which small electric currents are applied to the scalp with a wire covered in damp cotton pads. This will be done over the specific parts of the brain that are responsible for focusing attention to one side.
The investigators will compare the clinical outcomes of four interventions (1: behavioural, 2: tDCS, 3: a combination of both and 4: control).
The investigators hope that these studies will advance their understanding of what treatments may help people with neglect, and how they might work.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Action Training | Active Comparator | Training exercise which involves patients lifting up rods of different sizes and shifting their grip if this is too far to one side |
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| tDCS | Experimental | A constant 1mA current will be applied to the left (undamaged) side of the scalp with an electrode covered with a damp cotton pad (25 cm2). The current will be applied for 15 minutes per day, with a total of 10 sessions over 3 weeks. |
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| Action Training + tDCs | Experimental | This will involve the same procedure as in action training only but with tDCS applied for 15 minutes during the rodlifting. |
|
| Control training | Placebo Comparator | For the control training, patients will be asked to simply reach for the right hand side of each rod with their right (unaffected) hand and lift it |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial direct current stimulation | Other |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Behavioural Inattention Test (BIT) | 6 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance as measured by adherence to task instructions (percentage of intervention sessions, BIT tests completed) | baseline | |
| Compliance as measured by adherence to task instructions (percentage of intervention sessions, BIT tests completed) | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
History of epilepsy, medications or psychoactive drugs that can lower seizure threshold [imipramine, amitriptyline, doxepine, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, (MDMA, ecstasy), phencyclidine (PCP, angel dust), ketamine, gammahydroxybutyrate (GHB), alcohol, theophylline]. Withdrawal from alcohol, barbiturates, benzodiazepines, meprobamate, chloral hydrate. Patients who are pregnant or have suffered from a stroke-related seizure.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Monika Harvey, BSc (hons), MSc, PhD | Contact | 01413306174 | monika.harvey@glasgow.ac.uk |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34196963 | Derived | Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4. | |
| 33175411 | Derived |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 14, 2019 | |
| Reset | Aug 5, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 14, 2019 | Aug 5, 2019 |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D010468 | Perceptual Disorders |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Action Training |
| Other |
|
| Compliance as measured by adherence to task instructions (percentage of intervention sessions, BIT tests completed) | 6 months |
| Retention Numbers | baseline |
| Retention Numbers | 3 weeks |
| Retention Numbers | 6 months |
| 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. |
| 32498606 | Derived | Learmonth G, Benwell CSY, Marker G, Dascalu D, Checketts M, Santosh C, Barber M, Walters M, Muir KW, Harvey M. Non-invasive brain stimulation in Stroke patients (NIBS): A prospective randomized open blinded end-point (PROBE) feasibility trial using transcranial direct current stimulation (tDCS) in post-stroke hemispatial neglect. Neuropsychol Rehabil. 2021 Sep;31(8):1163-1189. doi: 10.1080/09602011.2020.1767161. Epub 2020 Jun 5. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |