Recommendations for the design of research involving brain surgery

Listening to people living with Parkinson’s

A new scientific paper, co-authored by Parkinson’s UK and people affected by Parkinson’s, has been published today. The paper outlines key recommendations to include in the design of research trials involving brain surgery. Drawing on insights from the GDNF trial – a study that explored the repeated infusion of a potential treatment directly into the brain. You can read more about the GDNF trial on our research blog.

The findings highlight the importance of listening to people with Parkinson’s and their loved ones to ensure their needs shape the future of research. This approach helps create trials that are more effective, ethical, and supportive.

You can read the full scientific paper in the journal called Trials.

Recommendations for future research

This paper highlights that research trials involving brain surgery have a greater emotional and physical burden compared to other ways of people taking part in research. And the much needed support required for participants is currently lacking. In addition, a significant gap exists in involving people with health conditions when designing trials involving brain surgery.

To address these gaps, the authors put forward a set of recommendations to ensure future trials are participant focused and meet the needs of those taking part.  

Key recommendations include:

• Involving people affected by Parkinson’s in trial design: Researchers should collaborate with patients and the public from the outset. For this to be effective this should involve careful design of meetings, regular communication, addressing concerns, and gathering feedback in a continuous and timely manner. The paper provides a case study from the GDNF trial on how this can be achieved.
• Providing a support package for participants: Support should be offered before, during, and after trials. This includes medical advice and support for emergencies outside the trial setting, as well as emotional and wellbeing check ins and support to manage the demands of the study.

How were these recommendations developed?

The recommendations were shaped by two key groups:

• A Patient and Public Involvement (PPI) group of 14 people, some of whom participated in the GDNF trial.
• A group of 12 people affected by Parkinson's joined two online workshops to co-create a support package for trials involving brain surgery.

The next step is for these recommendations to be tested in a research trial involving brain surgery to ensure they work in practice.

Thomas Phipps an author on this paper, who has Parkinson's and participated in the GDNF trial, said:

"I got involved in this work because I feel a responsibility to ensure that everyone taking part in research trials has the proper support in place, so they don’t have to go through some of the experiences I faced during the GDNF trial. My hope is that these recommendations serve as a duty of care for all participants in clinical trials.

"Listening to people like me, who have firsthand experience of taking part in a trial involving brain surgery, provides a crucial perspective - it’s very hard to truly understand the impact of something unless you’ve been through it yourself.

"For me, the key takeaways from this study are the importance of long-term follow-up, after someone finishes a trial. It is also crucial to ensure that the support package and involvement of people with the health condition are properly embedded into the planning and design phase of a clinical trial, forming a central part of the scrutiny of whether the trial is funded in the first place."

Reflections and thanks

Nikul Bakshi, our Research Involvement Lead and lead author of the paper, said:

"We would like to extend our heartfelt thanks to everyone who contributed to and collaborated on this important paper, especially Richard Campbell, our valued colleague, friend and co-author who sadly passed away while this manuscript was under review.

“The GDNF trial highlighted key questions around trial design and participant support. Valuable lessons have been learned – not only in the future of how GDNF is trialled but also in improving the design and support for studies involving complex procedures like brain surgery.

“Our hope is that these recommendations will guide future research, not just in Parkinson’s but across other fields, enhancing the participant experience and advancing the search for innovative treatments.”