Clinical trial: electrical brain stimulation

Recruiting to a new landmark trial to treat dementia by sending electrical currents deep into the brain

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Dr Nir Grossman, Group Leader at UK DRI at Imperial, is leading a new innovative trial using deep electrical currents applied to the brain of people living with Alzheimer's disease. Recruitment for participants is open and ongoing (as of June 2023).

The project is funded by Alzheimer’s Association via Part the Cloud (PTC) grants program, in partnership with Bill Gates Foundation.

Hopes for the technology

The technology – called temporal interference brain stimulation – involves applying electrodes to the scalp. The electrodes then send two harmless high-frequency beams into the brain, which do not interfere with healthy brain tissue. These beams are of slightly different frequencies – 2,000 Hz and 2,005 Hz – and when they cross they create a third current, a low-frequency wave of 5 Hz.

It is this new wave which is hoped will make all the difference as it has the same frequency at which brain cells fire – allowing it to spark diseased neurones back into action. It will be triggered in the hippocampus – an area deep in the brain responsible for forming new memories. This will hopefully revive the area's mitochondria, the energy source in every cell, which become damaged by Alzheimer's.

Evelyn Martin, Research Assistant on the trial explains, "The trial aims to investigate the role of brain activity in the progressive loss of function and structure of brain cells in Alzheimer’s disease using electrical brain stimulation. We have developed approaches to make small, transient alteration to neural activity in brain regions that are affected at the early stages of the disease, non-invasively via temporal interference (TI) deep brain stimulation. The outcome is to measure the changes in the brain's activity, as well as some of its energy sources and cognitive functions."

Joining the trial

Tests on healthy volunteers show the technique increases blood flow to the brain and results in improved results in facial-recognition tests. But the new trial, which started in October 2021, is the first time people living with Alzheimer's undergo the treatment.

Eligibility: The research team are seeking 12 additional patients with early-stage Alzheimer's. Any individual between 50-100 years old with a diagnosis of mild cognitive impairment or probable Alzheimer's disease. Other criteria include adequate visual & auditory acuity and capacity to give informed consent.

Exclusion criteria include but not limited to: medical, neurological or psychiatric illness that would interfere in completing assessments or impair the safety of the participant for brain stimulation. Other exclusion criteria include: known genetic mutation associated with familial Alzheimer’s disease or any other autosomal dominant form of dementia, any contraindication to MRI.

The study process: The trial will be a 3-week commitment and involves:

  • Pre-screening stage: a telephone interview to check eligibility and request access to medical records from GP.
  • Screening visit: blood test, safety questionnaires, clinical interview & examination, Allen's test, ECG, pregnancy test (if applicable) and a trial session with TI to ensure the volunteer is comfortable with the stimulation. This is a single visit which lasts approximately 4 hours and is carried out within 1-2 months before the stimulation and imaging sessions.
  • Ten sessions of up to 60 min of non-invasive brain stimulation separated by 24h (no sessions during weekends).
  • Brain imaging and cognitive assessment sessions before and after the stimulation period, including positron emission tomography (PET), magnetic resonance imaging (MRI) and neurocognitive assessments.

Recruitment is open and ongoing (as of June 2023).

All travel will be arranged by the research team. For individuals not based in London, accommodation will be arranged, and expenses covered.

To enquire further about the trial and discuss participation, please contact Research Assistants Julia Borella (julia.borella21@imperial.ac.uk) or Kaarin Šabad (k.sabad@imperial.ac.uk).

The team leading the trial

We have a team of amazing experts and researchers working on the project. They are very enthusiastic and excited to work with our volunteers to ensure that they have a pleasant experience and ensure success of the project.

Dr Nir Grossman is a Group Leader at UK DRI at Imperial College London and chief investigator on the project. He developed the TI technology with his collaborators at MIT during his postdoctoral position. He oversees all aspects of the project. ­­­­

Julia Borella, Research Assistant, UK DRI at Imperial College London joined the Interventional Systems Neuroscience lab during her MSc in Translational Neuroscience and has over a year of experience in delivering electrical brain stimulation. Julia is currently leading the recruitment and screening of volunteers and assisting with delivery of the intervention.

Kaarin Šabad, Research Assistant, UK DRI at Imperial College London completed an MSc in Neuroscience at King's College London, focusing on assessment of memory after neuromodulation. Since then, she has worked as a Cognitive Rehabilitation Assistant for clients with brain injuries. On this project, she leads the TI brain stimulation sessions.

Kety Alania, PhD Student, UK DRI at Imperial College London, has been working with the TI technology for nearly four years and has extensive experience with delivering electrical brain stimulation. On this project, she leads the TI brain stimulation sessions.

Dr Edward Rhodes, Postdoctoral Researcher, UK DRI at Imperial completed his PhD in 2018 during which he applied transcranial electrical/magnetic stimulation in an attempt to mitigate the symptoms of Parkinson's Disease. He has since joined the Interventional Systems Neuroscience lab and the UK Dementia Research Institute where he applies TI and other forms of electrical stimulation to patients with Dementia as well as those with various tremor disorders.

Dr Christopher Butler, Clinical Senior Lecturer in Dementia Research, Imperial College London is a practicing neurologist and lead clinician on project. He oversees participant screening and recruitment and other aspects of the project.

Dr Ines Volante, Senior Lecturer in Psychological Neuroscience, University of Surrey is an expert in variety of brain imaging methods and brain stimulation interventions. She oversees brain imaging and stimulation sessions as well as other parts of the project.