Launch of our Crowdfunding Initiative 2017
We are pleased to announce our Crowdfunding Campaign to raise funds for a new study on the Gupta Programme treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Just think of the difference we can make together by definitively showing how effective Amygdala & Insula Retraining (AIR) can be at treating these conditions. This independent study will be in association with a well-known independent clinic and research center that we are currently in talks with. This page outlines the key objectives of the study, the amount of funding required, and how you can contribute towards the study.
AMOUNT RAISED SO FAR: $50,000
We are well on the way to achieving our target, and with your support, we can help thousands of people around the world with this condition. Think about how many people are suffering unnecessarily and what health and healing we can bring to people. Please kindly pass on this information to others who might be interested. You can share this page on Social Media by clicking the share buttons at the top or bottom of this page.
We are open to obtaining funding from a variety of sources. However standard medical funding for research on ME/CFS is currently difficult to obtain. So, we are looking to raise funds through crowdsourcing, as well as, pursuing conventional avenues of grant support. If you have suggestions for sources of grant funding that we should apply to, please get in contact with us.
PURPOSE OF THE STUDY
The purpose of our study is to test the efficacy of a novel and cutting-edge treatment for ME/CFS known as the Gupta Programme. It will also help us learn about the most effective delivery of the programme, and how we can improve the treatment for the millions of people around the world who suffer from these conditions. Conducting a randomized, clinical trial of the Gupta Programme will offer clear insight into the potential contribution of this method to evidence-based integrative medical strategies aimed at the treatment of ME/CFS. A recent published Clinical Audit found that two thirds of patients reached a 80-100% recovery, and 92% of patients improved. You can view more about our research by clicking here.
The current estimate is that the study will cost $200,000. This cost-estimate has been derived by employing various cost cutting measures and automation of data collection to reduce costs. The study offers good value, in that, it offers a high-quality, gold-standard test of the effectiveness of the program in 150 patients for a cost that is a substantially less than that of typical randomized, controlled trials of this type. Cost-estimates are broken down further below. We are so confident in the expected benefits of this approach that the Gupta Programme will contribute $15,000 towards the study as a starting point.
If you wish to donate towards the cost of the study, you can click on one of the buttons below to make a Paypal or Credit Card payment towards the campaign. We are very grateful for any contributions that we receive. Once you contribute, you will be added to a list of sponsors of the Gupta Programme, and will be kept informed of our progress.
TO DONATE MORE THAN $10,000 PLEASE EMAIL firstname.lastname@example.org
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How will my donation be used?
The donation that you make will be ring-fenced, and only used towards a study on the efficacy of the Gupta Programme. If the study does not go ahead for any reason, we will return the money back to your credit card or Paypal account. The final study details may change from the details on this page, based on IRB submission and other factors.
What happens after my donation?
You will be kept informed of our fundraising campaign, and the timelines for the study.
In which currency can I donate?
You can donate in US$s on this page, using a Paypal account or credit or debit card.
What happens if I want to make a large donation, or know of someone that does?
Please contact us on email@example.com or call +44 (0)7770 425500 and we can discuss your sponsorship of our study.
If you want more information or have further questions, please email us.
DETAILS OF RESEARCH TEAM
We have assembled a team of experienced researchers who are keen to further independently test the efficacy of the treatment. The research team is as follows:
Research Site: We are currently in talks with a few sites to establish and finalise a good fit for the study
Lead Researcher: Dr Loren Toussaint, Associate Professor, Luther College, Iowa, USA. Dr Toussaint will be involved in writing the study protocol, database management, blind assessment and paper submission.
OVERVIEW OF STUDY
The study’s medical proposal is currently being finalised. In the meantime, here is a high level summary of how the study will work:
The purpose of this pilot study is to gather preliminary data on the efficacy and feasibility of a mind-body practice termed “Amygdala Retraining Techniques (ART)” on fatigue symptoms and quality of life in patients with Chronic Fatigue Syndrome (CFS). CFS is an incapacitating disorder characterized by profound fatigue, muscle pain, impaired memory, insomnia, and post-exertional malaise.
Current literature points to a centrally sensitized state in CFS. Amygdala Retraining Techniques are hypothesised to strengthen neurological inhibitory mechanisms in areas of the prefrontal cortex, insula and anterior cingulate. This helps to reduce hyper-stimulation of the autonomic nervous system by the amygdala and the insula. There are also aspects of the immune system which are hypothesised to be restimulated by the insula and other structures due to conditioning effects, causing acute symptomatology, as well as allowing opportunistic infections to flourish. The Gupta Programme is hypothesised to help retrain the insula, the amygdala, and other associated brain structures by the reinforcement of inhibitory mechanisms, so that the immune system and the autonomic nervous system can return to a normal state of homeostasis.
This single-blind, randomized, controlled study seeks to gather data on the efficacy of the Gupta Programme on symptoms in participants with CFS compared to a standard treatment. Quality of life-related variables (sleep, mood and quality of life) domains will also be measured.
150 Participants with a confirmed diagnosis of CFS will be recruited to this 6 month study. The patients will be recruited through an established clinic.
Participants who consent to the study will be equally and randomly allocated to one of three groups:
- Active Group: The Gupta Programme
- Primary Control: Standard Medical Interventions carried out at the Fatigue Consultation Clinic
- Secondary Control: Cognitive Behavioural Therapy (CBT)
- Active Group: The Gupta Programme
The active group will attend a 2-day training course (4 hours per day with rest breaks), where they will learn the key tools and techniques needed for this practice. The participants will then be sent home with a home study DVD program that explains and reinforces the Gupta programme. The main practices in the Gupta Programme include specialised neural cognitive restructuring techniques. They are supported by secondary supporting mindfulness based meditation, alternate nostril breathing and Neuro-Linguistic Programming techniques.
The participants will be asked to practice the intervention for a minimum of 45 minutes daily up to a maximum of 90 minutes daily. The daily practices include a few minutes of alternate nostril breathing in the morning followed by a simple 20 minute mindfulness meditation practice. They will have the option of four meditative practices to pick from: a mindfulness meditation practice that cultivates breath awareness or a mindfulness meditation practice that cultivates body awareness. Two further guided meditations are also provided. In addition to this, throughout the day they will practice the main “amygdala and insula retraining” techniques to interrupt negative signals to retrain the amygdala and insula’s hypothesized responses. These main retraining techniques will take only on average around 20-30 seconds to enact each time. The participants will also be encouraged to take a 20 minute evening meditation if they can make time for it. Again, they will have the option to pick from the four meditative practices above. The participants will receive scheduled phone calls or face to face sessions with a trained practitioner for 6 months to help them with obstacles they come across in the practice of the Gupta Programme and to tailor the training to them. In addition participants will have timely access to the study investigators for any immediate questions or challenges that arise with the practice.
2. Primary Control: Standard Medical Interventions carried out at the Fatigue Consultation Clinic
Medical interventions will be delivered in this control group, based on individual needs. These may, for example, include treatment of viruses and bacterial infections, orthostatic intolerance, or Anti-depressant, anti-anxiety and anti-convulsant medications.
3. Secondary Control: CBT
This control group will engage in a 6 month CBT programme with a qualified CBT therapist. The number of hours of face time will be similar to the active group.
Assessments will be made at baseline, 3 months, 6 months, 9 months and one year using validated questionnaires assessing: For example, general health (SF36), fatigue (MDFI), mental health (PHQ-9) and sleep quality and problems (Epworth Sleep Scale). In addition, the participants will keep a daily practice log where they record the total time spent daily in the practice of ART and any specific difficulties they encountered in the practice of the program.
Age 18 and older, men or women who meet CDC criteria for CFS
Hypo and hyper thyroidism, untreated
Hypo and hyperparathyroidism, untreated
Adrenal disorders, untreated
Chronic steroid use
Acute inflammatory rheumatological conditions
Obstructive Sleep apnea
Pain, uncontrolled as indicated by VAS score of 5 or greater
Potential Risks: This is a set of cognitive mind-body practices aimed at decreasing the stress response and retraining the higher cortical centers. We anticipate no risks to subjects based on Gupta’s 12 years of clinical experience with these techniques.
Gender/Minority Mix: This study will be available to all eligible patients, regardless of race or ethnic origin
If you require further information, please contact us.