Neurofeedback for phantom limb pain

JRCT ID: jRCTs052220058

Registered date:28/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Phantom limb pain
• Date of first enrollment: 28/06/2022
• Target sample size: 10
• Study type: Interventional

Intervention(s)

Two types of training are used as interventions: real training and sham training.
1) Real training. DecNef training is performed using a decoder created using magnetoencephalographic signals from when the subjects performed the grasping and opening movements with their intact hands. During the training, the magnetoencephalographic signals measured in real-time are input to the decoder, and the hand images that change according to the output are presented to the subjects. The subjects will be instructed to manipulate the hand image as if they were moving their own phantom hand. The same training is performed three times on the first day and five times a day thereafter. Training continues once a week for eight weeks, with three training sessions and brain activity measurements on the last day.
2) Sham training. Instead of the above decoder, the same training as above is carried out using the output results which was recorded during another patient's training.

Outcome(s)

• Primary Outcome: Change in average VAS in the 7 days after the end of the 2-month training from the average VAS in the 7 days before the training (%), comparison between real training and sham training

Secondary Outcome

(1) Change in average SF-MPQ2 total value in the 7 days following the end of the 2-month training period from the average SF-MPQ2 total value in the 7 days prior to training (%) , comparison between real training and sham training
(2) Number of days in which the VAS value after each training session is lower than 70% of the average 7-day VAS value before training , comparison between real training and sham training
(3) Number of adverse events other than pain change , comparison between real training and sham training
(4) The classification accuracy of magnetoencephalography during the phantom hand movements, and the changes of the classification accuracy before and after training

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

(1) Age between 18 and 85 years old at the time of obtaining consent, regardless of gender and severity of illness
(2) Patients who have given written consent to participate in this study
(3) Patients with upper limb amputation or complete brachial plexus avulsion, who have no sensation in a single upper limb, phantom limb sensation and phantom pain.
(4) Patients who have phantom pain that interferes with their daily life for more than 3 months, although the intensity of phantom pain is not determined by VAS.

Exclude criteria

(1) Patients with a severe neurological dysfunction that makes it impossible to perform the task.
(2) Patients with serious underlying diseases other than the target disease
(3) Other patients for whom participation in this study is deemed inappropriate by the principal investigator or sub-investigator.
(4) Patients with implanted devices such as pacemakers

Related Information

• Primary Sponsor: Yanagisawa Takufumi
• Source(s) of Monetary Support: AMED