DetectFoG : Detection of Gait Freezing Episodes in Parkinsonian Patients Using Inertial Measurement Units

Condition(s) studied

Investigational drug(s) / intervention(s)

Walk under 3 conditions (normal, physical tasks, verbal tasks): Each patient will have 2 visits : * First visit in the "ON" state phase, i.e. when their oral treatment allows the maximum improvement of dopamine-responsive parkinsonian symptoms. * A second visit will be scheduled 15 +/- 7 days from the first. Patients will then be assessed in the "OFF" phase after having stopped taking their antiparkinsonian medications for at least 12 hours before the start of the visit, in order to promote episodes of FOG For each visit, the patient will be asked to walk at a comfortable speed under the following 3 conditions: * Normal condition without addition of additional physical and verbal tasks * Condition with added physical tasks: The physical task of holding a ball in the center of a tray * Condition with added verbal tasks: The verbal task of saying as many words as possible starting with a specific letter. Conditions of passage are randomized per patient. Each subject will complete the course a maximum of 18 times in blocks of 3 conditions.

Study summary

Parkinson's disease is the second most common neurodegenerative disease in the world. One of these manifestations is the freezing of gait (FOG) which affects 50 to 80% of Parkinsonian patients. It is defined as a brief and episodic absence or marked reduction in the forward progression of the feet despite the intention to walk. FOG is one of the most disabling symptoms causing a greater risk of falling and a loss of autonomy for these patients. This symptom is little or not dopamine-sensitive and little improved by surgery (deep brain stimulation).

Although this symptom is common and debilitating, it is difficult to assess clinically. The objective assessment of the presence and severity of FOG episodes can be done with tests such as the New-Freezing of Gait Questionnaire (N-FOGQ) with however limitations. Indeed, this filmed examination is scored a posteriori and the accumulation of the administration times which makes it difficult to use in routine clinical practice. To overcome these limitations, the use of a diary completed by the patient himself is a simple alternative to assess this symptom, but studies show that patients abandon this practice in the long term and that it is not used by patients with cognitive impairment.

Recent advances in miniaturization have made it possible to create light and compact sensors to assess these events objectively. Inertial measurement units have been widely used in the literature to detect FOG episodes. The choice of the detection algorithms are a major issue in the scientific community. To date, due to the heterogeneity of the protocols, no method is currently required as a reference.

The objective is to evaluate the accuracy of a new algorithm to detect the number of FOG episodes in Parkinsonian patients. This evaluation will be done on the freeze-inducing walking path.

Eligibility

Primary outcome measure(s)

• Precision — Through study completion, an average of 15+/-7 days
  Every second of the course will be analyzed to define : * the "true positive" time: FOG detected by the algorithm and the two experts * True negative" time: FOG detected by neither the algorithm nor the two experts * False positive" time: FOG detected by the algorithm but not by the two experts * False negative" time: FOG not detected by the algorithm but detected by both experts For each course completed, accuracy will then be calculated as the ratio between the sum of the time spent in "true positive" and "true negative" divided by the time taken to complete the course. The average of these ratios is then calculated to estimate the accuracy of all runs performed, i.e. taking into account all repetitions performed by patients, regardless of run type and ON/OFF status.

Trial sites (1)

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