Multiple Sclerosis (MS) - Relapsing-remittingFatigue_SMNCT07624812
Behavioral and Electrophysiological Evidence of the Modulation of Fatigue in RR-MS
A study testing TENS therapy in people with Multiple Sclerosis (MS) - Relapsing-remitting, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
To furnish behavioral and electrophysiological evidence of the possible modulation of fatigue in Multiple Sclerosis - relapsing remitting form, through a verbal placebo. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Multiple Sclerosis (MS) - Relapsing-remitting
- What is being tested?
- TENS therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- right-hand dominant; ii) diagnosis of MS, Relapsing-Remitting (RR-) form (Polman et al., 2011); iii) score at the EDSS (Kurtzke, 1983) from 2 to 5.5.
Who cannot join
- relapse occurring over the previous six months; ii) a history of illness not less than one year; iii) first dose of disease-modifying or symptomatic treatments and any medication change in the previous three months; iv) reporting a score of equal to 2 or more at FSS (Kurtzke, 1983) cerebellar and brainstem scales; v) neuroimaging evidence of MS lesions at the spinal cord; vi) any known psychiatric or other neurological disorders, history of head injury, or stroke; vii)a score < 24 (Lezak et al., 2004) at the Italian version (Magni et al., 1995) at the MMSE (Folstein et al., 1975).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behavioral and Electrophysiological Evidence of the Modulation of Fatigue in Multiple Sclerosis, Relapsing Remitting Form: a Pilot Study
To furnish behavioral and electrophysiological evidence of the possible modulation of fatigue in Multiple Sclerosis - relapsing remitting form, through a verbal placebo.
- Being tested
- TENS therapy
- Keywords
- Placebo, Psychology, fatigue
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENS therapyBehavioural
A 30-min sham TENS intervention was administered combined with positive verbal suggestions.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group. | Experimental | Participants were told that transcutaneous electrical nerve stimulation (TENS) would be administered to expedite recovery from high exertion. To enhance the credibility of the sham treatment, a somatosensory tactile threshold was recorded beforehand. Two sham electrodes were then placed on the right dorsum of the hand and connected to a stimulator (DS7 Stimulator, Digitimer Ltd). Participants were informed that the device was active at a constant, sub-threshold current, making it imperceptible. Receives: Behavioral: TENS therapy |
| Natural History Group | No intervention | During the rest phase, participants were instructed to relax. Notably, no TENS treatment was administered, and no expectations regarding fatigue reduction were induced |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor performance
the overall number of flexions at the motor task
Measured: baseline
Secondary outcomes (1)
Readiness Potential
The Readiness Potential (RP) measured by EEG recordings
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Jan 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis (MS) - Relapsing-remittingStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federica Scarpina, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624812
- Sponsor's protocol ID
- 21A303
- Other IDs
- 2023/PR-Multi/002
- Acronym
- Fatigue_SM
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Volpino V, Navarra ME, Scarpina F, Piedimonte A, Scacchi M, Bianchi L, Mauro A, Carlino E. Motor placebo effect in obesity: how ergogenic aids can decrease fatigue and improve motor performance. Eat Weight Disord. 2025 Nov 10;30(1):85. doi: 10.1007/s40519-025-01794-5.
PubMed 41212312
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral and Electrophysiological Evidence of the Modulation of Fatigue in Multiple Sclerosis, Relapsing Remitting Form: a Pilot Study
- ClinicalTrials.gov ID
- NCT07624812
- Acronym / sponsor ID
- Fatigue_SM / 21A303
- Keywords
- Placebo, Psychology, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To furnish behavioral and electrophysiological evidence of the possible modulation of fatigue in Multiple Sclerosis - relapsing remitting form, through a verbal placebo.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group. | Experimental | Behavioral: TENS therapyParticipants were told that transcutaneous electrical nerve stimulation (TENS) would be administered to expedite recovery from high exertion. To enhance the credibility of the sham treatment, a somatosensory tactile threshold was recorded beforehand. Two sham electrodes were then placed on the right dorsum of the hand and connected to a stimulator (DS7 Stimulator, Digitimer Ltd). Participants were informed that the device was active at a constant, sub-threshold current, making it imperceptible. |
| Natural History Group | No intervention | –During the rest phase, participants were instructed to relax. Notably, no TENS treatment was administered, and no expectations regarding fatigue reduction were induced |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- right-hand dominant; ii) diagnosis of MS, Relapsing-Remitting (RR-) form (Polman et al., 2011); iii) score at the EDSS (Kurtzke, 1983) from 2 to 5.5.
Key exclusion criteria (1 listed)
- relapse occurring over the previous six months; ii) a history of illness not less than one year; iii) first dose of disease-modifying or symptomatic treatments and any medication change in the previous three months; iv) reporting a score of equal to 2 or more at FSS (Kurtzke, 1983) cerebellar and brainstem scales; v) neuroimaging evidence of MS lesions at the spinal cord; vi) any known psychiatric or other neurological disorders, history of head injury, or stroke; vii)a score < 24 (Lezak et al., 2004) at the Italian version (Magni et al., 1995) at the MMSE (Folstein et al., 1975).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENS therapyA 30-min sham TENS intervention was administered combined with positive verbal suggestions. | Behavioural | Placebo group. |
Primary outcome
Motor performance
Time frame: baseline
the overall number of flexions at the motor task
1 secondary outcome
Readiness Potential
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Background: PubMed 41212312Volpino V, Navarra ME, Scarpina F, Piedimonte A, Scacchi M, Bianchi L, Mauro A, Carlino E. Motor placebo effect in obesity: how ergogenic aids can decrease fatigue and improve motor performance. Eat Weight Disord. 2025 Nov 10;30(1):85. doi: 10.1007/s40519-025-01794-5.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
Related trials for Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Not yet recruiting
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS therapy in people with Multiple Sclerosis (MS) - Relapsing-remitting, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor performance (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07624812, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.