The world’s first mental health treatment using ultrasound

Case Study  – whole brain machine interface clinical trial

About the medical device trial

PHARMExcel CRO has partnered with Barking and Havering NHS Trust to manage a UK-based, investigator-led study testing the safety and effectiveness of a next-generation brain-machine interface. The clinical trial is funded by a grant from the Advanced Research and Invention Agency (ARIA). The innovative device, known as the Forest 1 device, uses ultrasound technology to stimulate the brain and help improve people’s mood and reduce depression.
The device has been developed by Los Angeles-based company Forest Neurotech.

Unlike current technologies such as deep brain stimulation, which only target a single area of the brain, this new technology can target the whole brain with pinpoint accuracy.

As the academic sponsor and project-lead, Barking and Havering NHS Trust brings scientific leadership and specialist clinical expertise. PHARMExcel, as CRO, ensures robust clinical trial management, regulatory oversight, and quality compliance to support the success of this ground-breaking study.

Together, the collaboration combines academic independence with commercial efficiency—accelerating the clinical pathway of a new therapy.

Bespoke solutions for our client

We provide a flexible, ‘pick and mix’ service offering – allowing the Sponsor to engage the specific services they need tailored to the study requirements which include:

  • Protocol Development
  • Clinical Monitoring & Site Management
  • Project Management
  • Regulatory Strategy & Submissions
  • Ethics & HRA Co-ordination
  • Trial Management & Oversight
  • Safety Management
  • Data Management

The value of our CRO – academic partnership

This project demanded a CRO experienced in first-in-human device trials and academic collaboration. PHARMExcel’s expertise in regulatory strategy, particularly with medical devices, will ensure that the UNI project maintains full compliance with UK MHRA and NHS R&D requirements.

Our agile team supports rapid ethics submissions and works closely with the Trust to align academic goals with commercial trial standards—ensuring the study launches on time, with patient safety and scientific rigor front and centre.

Through our proactive collaboration, the study will be able to begin assessing this novel technology’s clinical viability faster than traditional models.

Mental health clinical study key milestones

Thank you to our collaborators and their expertise

Academic Clinical Trial Sponsor

  • Barking, Havering and Redbridge University Hospitals NHS Trust

Lead Clinical Investigator

  • Aimun Jamjoom
    Consultant Neurosurgeon, Queen’s Hospital, London
    Expertise: Traumatic brain injury, cerebrospinal fluid disorders, brain haemorrhage, and awake functional mapping.

"The opportunity to work on this study is hugely exciting as it has potential to make a real difference in improving the lives of people with mental health issues. We’ll be researching the safety of the device, and looking to see if we can improve symptoms of depression. It holds the promise of delivering a life-changing therapy for people with depression and anxiety who don’t respond to medication."

Aimun Jamjoom, Consultant Neurosurgeon and CI

Technology Developer

  • Forest Neurotech
    Healthcare technology innovators for Parkinson’s disease, treatment-resistant depression, and cognitive-motor dissociation in critical care settings. Developer of the Ultrasonic Neural Interface (UNI) technology, the central platform for brain imaging and modulation in this project.

Key Team Members at Forest Neurotech:

  • Dr Sumner Norman
    PhD in Clinical Neurotechnology and Brain-Computer Interfaces (BCI)
  • Dr Tyson Aflalo
    PhD in Systems Neuroscience, Princeton
    Neurostimulation, recording, and computational modelling lead.
  • William Beiderman
    PhD in Electrical Engineering
    Hardware and device innovation lead.Known for: Inventing “neural dust”, developed Dexcom G7 glucose monitor at Verily.

Patient Stakeholders

  • Patient Population 1: Individuals with a decompressive craniectomy (e.g. from traumatic brain injury, stroke, or infection).
  • Patient Population 2: Patients undergoing awake craniotomy for brain tumour removal with language mapping.
    • Role: Participants in feasibility and tolerability trials for the wearable UNI.
    • Selected for existing skull access allowing interface with the brain.

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Why does Barking and Havering NHS Trust value working with PHARMExcel?

PHARMExcel brings a commercially efficient, academically sensitive approach to the trial. As a development partner, we deliver an ISO-accredited infrastructure, expert project coordination, and clear regulatory pathways—enabling quality outcomes from the clinical trial.

“PHARMExcel understands the needs of academic-led innovation. Our team brings structure, speed, and quality to this complex neurotechnology study—ensuring patient safety, regulatory compliance, and progress. It’s a true partnership.”
Yvanne Enever, CEO & Founder of PHARMExcel

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