A two-year trial shows deep brain stimulation using an electrical implant works better than drugs alone at a much earlier stage in the disease than previously found.
There was a 26 per cent improvement in the quality of life for patients after surgery, compared with no improvement for those on drugs alone. …show more content…
Coordination improved by 50 per cent, while activities such as speech, handwriting, dressing and walking improved by 30 per cent for those having the operation.
They also took less medication and had fewer drug-related complications, while those on drugs alone had to increase the dose.
The latest trial involving 251 patients in France and Germany gave deep brain stimulation to people who had suffered Parkinson’s for around seven years.
What is Parkinson 's Disease?Parkinson’s is caused by a lack of dopamine in the brain due to the death of nerve cells. Symptoms may vary greatly from day to day.
According to the charity Parkinson’s UK, up to one in 20 of those diagnosed with Parkinson’s disease every year are under 40.
Tremor (shaking) affects about 70 per cent of people with Parkinson’s. It often starts in one hand, spreads up the arm and then to the foot on that side of the body.
The exact cause is not known. It usually occurs when a person’s muscles are relaxed and improves when they start an activity. In the early stages, squeezing or rolling a ball or pen in the hand can suppress a tremor.
Other common symptoms are slowness of movement and muscle stiffness. Less visible symptoms include sleep difficulties, depression and anxiety, as well as constipation and sweating.
Parkinson’s may affect talking, walking and swallowing. Being unable to do such everyday things can make this a frustrating and isolating condition.
Drugs are the most common treatment. They help to manage the symptoms, including tremor, but do not stop its progression. Ideally, patients should have access to a Parkinson’s nurse, who could help to manage symptoms and provide emotional support.
Research into gene therapy and stem cell therapy is ongoing. It’s hoped that these may slow down or halt the condition.
Exercise and an active lifestyle help with movement, balance and mood. Singing and amateur dramatics can aid breathing and speech.
The three main symptoms of Parkinson’s disease are: involuntary shaking of particular parts of the body (tremor) muscle stiffness that can make everyday tasks difficult (rigidity) slow physical movements (bradykinesia)
Other symptoms can include: involuntary muscle jerking (dyskinesia) depression daytime sleepiness swallowing difficulties (dysphagia)
A drug called levodopa is used to relieve symptoms, although its effectiveness is reduced after three to five years of use. Its long-term use can trigger side effects such as: temporary immobility uncontrollable, jerky muscle movements (dyskinesias)
This research was carried out in order to see if deep brain stimulation could relieve some of the side effects associated with levodopa.
The researchers recruited 251 people from Germany and France with Parkinson’s disease and early movement problems. To be included, patients had to be between 18 and 60 years, have had Parkinson’s for at least four years, and not have a severe form of the disease.
Patients with major depression or dementia were not included in this study.
They were randomly assigned to receive either neurostimulation plus medical therapy (124 people), or medical therapy only (127 people).
The neurostimulation group underwent surgery to have electrodes implanted into certain parts of the brain and were fitted with a neurostimulator that was connected to the electrodes.
The electrical implant generated small electrical signals to stimulate the brain and was controlled by a handheld device. These electrical signals block abnormal nerve signals, which are thought to trigger the symptoms of Parkinson’s disease.
Medical therapy involved standard drug therapy for Parkinson’s disease. All patients were then assessed at five months, one year and two years.
The primary outcome of the trial was disease-related quality of life at two years, which was assessed using the Parkinson’s disease questionnaire (PDQ-39). The PDQ-39 is essentially a scoring system that assesses the extent that the disease has impacted a person’s quality of life. Scores in the questionnaire ranged from 0 to 100, with higher scores indicating worse function.
Other outcomes measured were: parkinsonian motor disability activities of daily living …show more content…
(ADLs) levodopa-induced motor complications time with good mobility and no dyskinesia adverse events
The researchers compared the outcomes of participants who received neurostimulation and medical therapy with those who only received medical therapy.
They used a statistical technique called an intention-to-treat analysis, which takes into account all participants that started the study and is the best way of analysing data from this type of study.
The study, which involved 251 people with early-stage Parkinson’s disease, looked at the quality of life of participants after they received different treatments for two years. One group of patients was treated with brain stimulation and medication, while the other group only received medication.
Deep brain stimulation acts like a kind of neural pacemaker, using electrical pulses to stimulate areas of the brain that have been damaged by Parkinson’s.
Researchers found that quality of life improved significantly by 26% among patients who received brain stimulation and medical therapy, compared with a decline of 1% in quality of life among participants who only received medication.
While these are very impressive results, we need to bear in mind that this was a small study. The findings need to be replicated in larger studies before we can say that this type of treatment is safe and effective.
Earlier trials had successfully tested the procedure on patients with advanced disease, after 12 years.
Gunther Deushcl, Professor of Neurology at Christian-Albrechts University in Kiel, and lead investigator of the study for Germany, said: ‘These results signal a shift in the way patients with Parkinson’s disease can be treated. 'They prove that deep brain stimulation therapy can improve patients’ quality of life even in the earlier stages of Parkinson’s disease, when clinicians traditionally rely solely on drugs.’
About 10,000 people are newly diagnosed with Parkinson’s each year, and 125,000 are living with the disease at any
time.
Most are over 60, but a significant number are young.
It is a progressive neurological condition that causes symptoms of tremor and muscular rigidity or stiffness that can make walking, talking and even writing difficult or frustrating.
There is no cure for Parkinson 's, but a range of treatments help control symptoms.
Patients having deep brain stimulation (DBS) are fitted with a neurostimulator, a device similar to a heart pacemaker, which is connected to electrodes placed in certain parts of the brain.
The electrical implant is connected to a small battery under the skin in the person 's chest or abdomen to generate small electrical signals to stimulate the brain.
This is controlled by a hand-held device which can be switched on and off.
When switched on, the patient benefits from the blocking of abnormal nerve signals which trigger the disabling symptoms.
The operation costs around £30,000 and is currently only considered on the NHS for patients with very advanced disease.
The latest trial using a DBS system made by US firm Medtronic is the first to look at patients with early symptoms.
After two years, those having surgery and drugs had a 26 per cent improvement in quality of life compared with drugs alone and a range of other advances.
Dr Patricia Limousin, National Hospital for Neurology and Neurosurgery, University College London Hospitals, said ‘These results are very exciting for people with Parkinson’s in the UK. Often only patients with very advanced stage of the disease are considered for surgery.
‘This study demonstrates that deep brain stimulation can lead to a marked improvement in quality of life for people who are earlier in the progression of the disease.
‘We can offer our patients a truly different option to manage early stage motor complications.’
Dr Kieran Breen, Director of Research and Innovation at Parkinson’s UK, said ‘This new study is the first compelling evidence to demonstrate that deep brain stimulation - brain surgery traditionally used to treat the later stages of Parkinson 's - may be beneficial for some people in the earlier stages of the condition.
‘In this study of 251 people, the researchers found that that those who had had deep brain stimulation reported a better quality of life two years later, than those who had chosen not to have the surgery.
‘Studies like these are vital to help doctors identify those most likely to benefit, and to make sure people with Parkinson’s at whatever stage have access to this important treatment.
‘However, it is important to remember that not all people with Parkinson’s are suitable for this surgery, and though the results can be dramatic - with a reduction in tremor and stiffness - not everyone who has it will find their lives transformed.
What were the basic results?The participants (average age 52 years) had lived with Parkinson’s disease for an average of 7.5 years. At the two-year follow-up, the key finding was that quality of life significantly improved by 26% in the neurostimulation plus medical therapy group, an average change from a baseline of eight points on the PDQ-39.
This is in comparison with a 1% decline in quality of life among the medical therapy alone group (an average decline of 0.2 points on the PDQ-39).
Researchers also found that neurostimulation plus medical therapy was superior to medical therapy alone when looking at: motor disability activities of daily living (ADLs) levodopa-induced motor complications time with good mobility and no dyskinesia
A total of 68 (54.8%) patients in the neurostimulation group had at least one serious adverse event, compared with 56 (44.1%) in the medical therapy only group. Statistical testing comparing adverse events between groups was not reported. A serious adverse event was defined as an event that led to hospitalisation, disability or death.
Depression was reported more frequently in the neurostimulation group, and psychosis was reported more frequently in the medical therapy only group. There were 26 serious adverse events related to surgery or the implanted device, of which 25 resolved completely and one left a skin scar.
Medication use was significantly changed in both treatment groups. The levodopa-equivalent daily dose was reduced by 39% in the neurostimulation group, but was increased by 21% in the medical therapy group, with a difference of 609mg between the groups.
ConclusionThis study provides some compelling early evidence that earlier intervention using brain stimulation and medication together may benefit patients with early-stage Parkinson’s disease.
Improvements in patients’ quality of life were found after two years of therapy when compared with patients who took medication alone. Currently, deep brain stimulation is only used in people with advanced Parkinson’s disease. unlike acupuncture, for example, you cannot carry out ‘sham’ brain surgery. This means there may have been a placebo effect at work, where patients may have reported quality of life scores differently because they knew they were receiving a new treatment.
These findings need to be replicated in larger studies before definitive conclusions can be drawn about the effectiveness and safety of this type of treatment. If further studies find similar results, this could change the way early-stage Parkinson’s disease is treated.
References href="http://www.dailymail.co.uk/health/article-2280393/Brain-implant-works-better-medication-brings-hope-thousands-Parkinsons-sufferers.html">Brain implant that works better than medication brings hope to thousands of Parkinson’s sufferers. Mail Online, February 18 2013
Schuepbach WMM, Rau J, Knudsen K, et al.href="http://www.nejm.org/doi/full/10.1056/NEJMoa1205158">Neurostimulation for Parkinson’s Disease with Early Motor Complications. New England Journal of Medicine. Published online February 14 2013