Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSpaulding Rehabilitation Hospital
About this trial
The purpose of this study is to assess the effects of tDCS in combination with TUS for the treatment of pain in subjects with Carpal Tunnel Syndrome. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to provide informed consent to participate in the study
Subjects between 18 to 80 years old
Having symptomatic CTS spreading within or beyond the median nerve distribution (demonstrating 'extra-median spread'), involving at least 1 wrist, with chronic pain as defined by International Association for the Study of Pain (existing pain for at least 6 months and having pain on at least half the days in the past 6 months with an average of at least a 3 on a 0-10 VAS scale).
Pain resistant to first line therapies of chronic pain (pain still present at lower levels most of the time following therapy)
Disqualifiers
Subject is pregnant
intracranial metal implant
implanted brain medical devices
History of alcohol or drug abuse within the past 6 months as self-reported
Trial design
Design model
Parallel
Treatments tested in this trial
transcranial Direct Current Stimulation (tDCS)
DeviceSubjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. In the sham group, the tDCS device will not be active for the full 20 minutes.
Transcranial Ultrasound (TUS)
DeviceSubjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.
Treatment groups
95 Participants
are divided into 2 treatment groupsGroup A: Active tDCS + Active TUSExperimental treatment 2 interventions
Group B: Sham tDCS + Sham TUSSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
Visual Analogue Score (VAS)
Changes in the Visual Analogue Scale (VAS) for pain will be measured in order to determine whether anodal transcranial direct current stimulation in conjunction with transcranial ultrasound is effective in reducing pain in subjects with Carpal Tunnel Syndrome. The VAS scale goes from 0 up to 10, where 0 means no pain at all and 10 means the worst imaginable pain.
Time frame
9 weeksSecondary outcomes
1
Verbal Rating Scale (VRS)
Changes in the Verbal Rating Scale (VRS) for pain will be measured in order to determine whether anodal transcranial direct current stimulation in conjunction with transcranial ultrasound is effective in reducing pain in subjects with Carpal Tunnel Syndrome. The VRS minimum value is no pain and the maximum value is severe pain. Being severe pain the worst outcome.
Time frame
Measured for approximately for a total 9 weeks2
Visual Analog Mood Scale (VAMS)
The investigators will measure safety of tDCS and TUS by measuring changes in the Visual Analog Mood Scale. This scale will range from zero (low or worst mood) to 10 on anxiety, depression, sleepiness and stress.
Time frame
Measured for approximately for a total 9 weeks3
Montreal Cognitive Assessment (MOCA)
The investigators will monitor the safety of tDCS and TUS in subjects by measuring any changes in cognition, attention, and focus with the MOCA. MOCA scores range between 0 and 30, a score of 26 and higher generally considered normal.
Time frame
Measured for approximately for a total 9 weeks4
tDCS Side Effects Questionnaire
At each session, subjects will complete a questionnaire to evaluate potential adverse effects of stimulation (headache, neck pain, mood alterations, and seizures) on a 4-point scale, where 1 is absent and 4 is severe. The scale will also be administered at the follow-ups.
Time frame
Measured for approximately for a total 9 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Spaulding Rehabilitation Hospital
Lead sponsor
Highland Instruments, Inc.
Collaborator
Source ClinicalTrials.gov