Efficacy of tDCS on Pain in Multiple Sclerosis

Not Applicable

• Conditions: Multiple Sclerosis

• Registration Number: NCT03389217
• Lead Sponsor: University Hospital of Ferrara

Brief Summary

Pain is a common symptom experienced by people with MS and can significantly interfere with participation in the activities of daily living and adversely affect health-related quality of life. Pain in people with MS has the potential to become chronic, as a consequence of neuronal reorganization. Transcranial Direct Current Stimulation (tDCS) promotes the modulation of brain activity and its prolonged and continuous application can effect plastic modification. Combining tDCS with rehabilitation treatment may have effect in reducing pain in people with MS. This is a pilot randomized control trial to test the effects of tDCS in MS-related pain rehabilitation, its efficacy on pain (intensity, quality, interference with physical functioning), catastrophizing, emotional functioning and quality of life. Furthermore, we will explore the effects on pressure pain threshold and EEG recording. Correlations between sample characteristics and pain features will be investigated. Considering role of tDCS on neuropsychological functions, selective attention will be assessed.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-16
• Study Start: 2017-12-01
• Study First Submitted QC: 2018-01-02
• Study First Posted: 2018-01-03
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-05-25
• Primary Completion: 2022-12-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• chronic pain defined as a constant or intermittent sensory symptom with unpleasant feelings or pain, lasting more than 3 months with a minimum score of 3 points on the Numeric Rating Scale (NRS) for pain perception;
• lack of MS worsening in the three months just before the intervention period;
• cognitive functioning to give informed consent identified by a Mini-Mental Status Examination (MMSE) score ≥ 24/30.

Exclusion Criteria

• worsening of MS-related conditions or changes in drug therapy or any other confounding factor during the study;
• rehabilitation treatments or Botulinum toxin injections during the three months preceding the start of the study;
• intracranial metal implants that can be stimulated, incorrectly positioned, or overheated by the electric current;
• severe cardiopulmonary, renal, and hepatic diseases;
• pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Numeric Rating Scale (NRS)	4 weeks	Core outcome measure of pain intensity in chronic pain treatments' clinical trials

Secondary Outcome Measures

Name	Time	Method
Pressure Pain Threshold (PPT)	1 week, 4 weeks, 8 weeks	PPT is measured to test presence of widespread pressure hyperalgesia as sign of abnormal pain processing.
Short Form McGill Pain Questionnaire (SF-MPQ)	1 week, 4 weeks, 8 weeks	Assessment of sensory and affective dimensions of typical whole-body pain intensity.
Patient Global Impression of Change (PGIC)	1 week, 4 weeks, 8 weeks	Measure of participants' assessment of the clinical importance of their improvement or worsening over the course of a treatment
Pain Catastrophizing Scale (PCS)	1 week, 4 weeks, 8 weeks	Assessment of a tendency to misinterpret or exaggerate apparently threatening situations that can lead to increased sensitivity to pain.
Coping Strategies Questionnaire (CSQ)	1 week, 4 weeks, 8 weeks	Assessment of the frequency of coping strategies in response to pain.
Beck Depression Inventory II (BDI-II)	1 week, 4 weeks, 8 weeks	Assessment of severity of common depressive symptoms.
MS Quality of Life - 54 (MSQOL-54)	1 week, 4 weeks, 8 weeks	Multidimensional health-related quality of life measure that combines both generic and MS-specific items
Go/No-go Task	1 week, 4 weeks, 8 weeks	Assessment of selective attention
Fatigue Severity Scale (FSS)	1 week, 4 weeks, 8 weeks	Assessment of common features of fatigue in patients with multiple sclerosis
Brief Pain Inventory (BPI)	1 week, 4 weeks, 8 weeks	Assessment of the extent to which pain interferes with general activity, mood, walking, work, relationship with others, sleep, and enjoyment of life.
Electroencephalography (EEG) recordings	1 week, 4 weeks, 8 weeks	EEG data will be recorded to test presence of particular brain activity in condition of pain chronicity and catastrophization.

Trial Locations

Locations (1)

Ferrara University Hospital; 🇮🇹 Ferrara, Italy