INTERIM REPORT for "Pilot Study on Safety and efficacy of the Non-invasive Transcranial Stimulation to Relieve Neuropathic Pain in Patients with CRPS"
Helena Knotkova, PhD
Beth Israel Medical Center,
Department of Pain Medicine and Palliative Care
OBJECTIVES OF THE STUDY
To determine the effect of repetitive anodal tDCS stimulation at intensity of 2 mA on pain, somatosensory abnormalities, and motor function in patients with CRPS.
The study was proposed as a double-blind sham controlled trial with an open-label extension, for 24 CRPS patients randomized 2:1 in favor of real stimulation.
18 patients have been enrolled in the study.
Up to date, 83 potential participants have been identified. Twenty five of them did not qualify at the pre-screening or could not participate in the study (e.g. due to living far from the NYC area or for personal reasons), 12 did not want to participate in the study, contact was lost with 1 patient, in 12 cases the attending physician did not recommend patient’s participation (e.g. due to non-compliance or psychological/psychiatric issues), 15 patients are in the process of the first contact or scheduling for the screening visit.
18 patients have been enrolled in the study. Two of them did not meet the Inclusion/Exclusion criteria at the Screening Visit. Sixteen patients met the inclusion/exclusion criteria and were eligible for tDCS treatment. Six of them never started (never received tDCS treatment) and discontinued from the study for following reasons: 1 patient moving from the NYC area; 2 patients working full time and could not take 5 consecutive days off; the family did not agree with the patient’s participation in the study – 1 patient, a contact lost with 1 patient after the enrollment; 1 patient lost her job and needed to focus on priorities in her life.
None of enrolled patients was discontinued after starting the treatment.
Nine patients completed the study, and 1 patient is ongoing.
As the study has been done in a double-blind paradigm, we can not unblind and evaluate the data until the study is finished. However, there was only one participant who did not report any pain relief in the blinded part as well as in the open-label extension. Other patients either did not opt to participate in the open-label extension, or are scheduled for the open-label extension, or reported a substantial pain relief in the double-blind part.
PROBLEMS IN MEETING OBJECTIVES
We did not experience any problems in meeting the objectives of the study. However, it is necessary to point out that many of pre-screened and screened patients did not qualify or could not participate in the study. Thus, we still need referrals of potential participants.
ANY BUDGETARY QUESTIONS?
FUTURE PLANS FOR THIS PROJECT
The results of the project will be presented on the World Congress on Pain (Glasgow, Scotland, UK) in August 2008, and at the Annual Meeting of the American Pain Society in 2009.
PUBLICATIONS RESULTING FROM THE PROJECT
As we can not unblind the data until the end of the project, there have not been any publications based on the study data yet.
Added February 6, 2008