FibromyalgiaNCT03371225

Optimized tDCS for Fibromyalgia: Targeting the Endogenous Pain Control System

A study testing Active tDCS and Active Exercise in people with Fibromyalgia, run by Spaulding Rehabilitation Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Fibromyalgia
What is being tested?: Active tDCS and Active Exercise
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 116 participants
Where: 1 siteUnited States
Study dates: 1 May 2019to 26 Oct 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age range 18-65 years,
Diagnosis of FM pain according to the ACR 2010 criteria (existing pain for more than 6 months with an average of at least 4 on a 0-10 VAS scale) without other comorbid chronic pain diagnosis,
Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine,
Must have the ability to feel sensation by Von-Frey fiber on the forearm,
Able to provide informed consent to participate in the study.

Who cannot join

Clinically significant or unstable medical or psychiatric disorder,
history of substance abuse within the past 6 months as self-reported (if subject reports a history of substance abuse, we will confirm using DSM V criteria),
Previous significant neurological history (e.g., traumatic brain injury), resulting in neurological deficits, such as cognitive or motor deficits, as self-reported,
Previous neurosurgical procedure with craniotomy,
Severe depression (If a patient scores >30 on the Beck Depression Inventory, one will obtain clearance. If one does not pass the medical clearance, one will not be included in the study)
Pregnancy (as the safety of tDCS in pregnant population (and children) has not been assessed (though risk is non-significant), the investigators will exclude pregnant women (and children). Women of child-bearing potential will be required to take a urine pregnancy test during the screening process and at every week of stimulation),
Current opiate use in large doses (more than 30mg of oxycodone/hydrocodone or 7.5mg of hydromorphone (Dilaudid) or equivalent),
Patients will be excluded when they have increased risk for exercise

Trial locations and contacts

1 site in 1 country.

United States1 site

Spaulding Rehabilitation Hospital for Continuing Care
Cambridge, Massachusetts, 02138

Other trials in United States

About this study

This trial aims at understanding the mechanisms of optimized transcranial direct current stimulation (tDCS) (16 tDCS sessions combined with exercise)] on pain control. Optimized tDCS can lead to stronger engagement of the endogenous pain regulatory system that will ultimately lead to increased pain relief in patients with fibromyalgia (FM). Therefore, the investigators designed a 2x2 factorial mechanistic trial [tDCS (active and sham) and aerobic exercise (AE) (active and control)] to evaluate the effects of 4 weeks of tDCS coupled with exercise on the endogenous pain regulatory system assessed by conditioned pain modulation (CPM) and central sensitization as assessed by temporal slow pain summation (TSPS), and compared to either intervention alone and to no intervention.

Read the detailed description

Recent evidence has suggested that FM pain can be related to deficits in pain endogenous regulatory control and that novel non-pharmacological interventions, such as tDCS can modulate this system and, consequently, reduce pain intensity. Widespread pain in FM is thought to represent enhanced pain sensitivity that is maintained by central mechanisms. This suggests changes in the descending pain control mechanisms and a possible relationship with the central sensitization phenomenon. Recent evidence has suggested that pain inhibitory pathways are affected in FM; thus, further understanding these pathways' role can significantly change how the treatment of this condition. In this study the investigators will test the effects of two interventions -tDCS and aerobic exercise - on the modulation of the endogenous inhibitory pain system in fibromyalgia.

Conditions: Fibromyalgia
Being tested: Active tDCS, Active Exercise, Sham tDCS, Sham Exercise
Medical subject headings: Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Active tDCSDevice
Also called tDCS
Active tDCS: A 1x1 Low-intensity DC Stimulator will be used to deliver direct current through rubber electrodes in saline soaked sponges. The anode will be placed over the left primary motor cortex (M1) while the cathode will be placed over the contralateral supra-orbital area. 20 minutes of tDCS will be applied.
Active ExerciseProcedure or surgery
Also called Aerobic Exercises
Participants will walk briskly in a treadmill (as to keep at 60-70% maximum heart rate) for 30 minutes
Sham tDCSDevice
Also called Placebo tDCS
Active tDCS: A 1x1 Low-intensity DC Stimulator will be used to deliver direct current through rubber electrodes in saline soaked sponges. The anode will be placed over the left primary motor cortex (M1) while the cathode will be placed over the contralateral supra-orbital area. Only 30 seconds of current will be applied for the sham condition.
Sham ExerciseProcedure or surgery
Also called Placebo Aerobic Exercise
Participants will walk in a treadmill (as to keep at 10% within their baseline heart rate) for 30 minutes.

Study groups in NCT03371225
Study group	Role	What they receive
Active tDCS and Active Exercise	Experimental	Active tDCS for 20 min Active exercise (60-70% max HR) for 30 min Receives: Device: Active tDCS; Procedure: Active Exercise
Sham tDCS and Active Exercise	Active comparator	Sham tDCS for 20 min Active exercise (60-70% max HR) for 30 min Receives: Procedure: Active Exercise; Device: Sham tDCS
Active tDCS and Sham Exercise	Active comparator	Active tDCS for 20 min Sham exercise (within 10% baseline HR) for 30 min Receives: Device: Active tDCS; Procedure: Sham Exercise
Sham TDCS and Sham Exercise	Sham comparator	Sham tDCS for 20 min Sham exercise (within 10% baseline HR) for 30 min Receives: Device: Sham tDCS; Procedure: Sham Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

Conditioning Pain Modulation (CPM)
Pain intensity was measured using the Numeric Pain Scale (NPS; 0 = no pain, 10 = worst pain). Higher scores indicate worse pain. A "pain-6 temperature" was first identified (temperature that elicits NPS = 6).
Test stimulus: Pain-6 temperature applied for 30s; participants rated pain at 10, 20, and 30s. The test-stimulus score is the average of the three NPS ratings.
Conditioned stimulus: After 5 minutes, the left hand was immersed in 10-12°C water for 30s while the same pain-6 temperature was applied again. Pain was rated the same way, and the conditioned-stimulus score is the average of the three NPS ratings.
CPM calculation = (test-stimulus average) - (conditioned-stimulus average). Positive values = better endogenous pain inhibition; negative values = worse.
Measured: 6 weeks
Temporal Slow Pain Summation (TSPS)
Participants first determined the temperature that elicited Numeric Pain Scale (NPS) = 6 ("pain-6"). Using this temperature, a train of 15 heat pulses (0.4 Hz) was delivered to the right forearm with a TSA-II thermode.
Pain was rated using the NPS after the 1st and 15th heat stimulus.
TSPS calculation:
TSPS = NPS rating after the 15th stimulus - NPS rating after the 1st stimulus. Higher TSPS values represent greater temporal pain summation (worse outcome).
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 201926 Oct 2025

First posted13 Dec 2017
Study start1 May 2019
Primary completion26 Sep 2024
Study completion26 Oct 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for FibromyalgiaStudies of the same condition, open and under way.
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: Factorial
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03371225
Sponsor's protocol ID: 2017P002524
Status last verified: Nov 2025
First submitted: 20 Nov 2017
Last updated: 10 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Upon completion of the trial and after publication of the primary manuscript, we plan to publish the de-identified dataset following the guidelines of our institution (Spaulding Rehabilitation Hospital/Partners Healthcare and Harvard Medical School).

Publications

Pacheco-Barrios K, Teixeira PEP, Martinez-Magallanes D, Neto MS, Pichardo EA, Camargo L, Lima D, Cardenas-Rojas A, Fregni F. Brain compensatory mechanisms in depression and memory complaints in fibromyalgia: the role of theta oscillatory activity. Pain Med. 2024 Aug 1;25(8):514-522. doi: 10.1093/pm/pnae030.
PubMed 38652585
Castelo-Branco L, Uygur Kucukseymen E, Duarte D, El-Hagrassy MM, Bonin Pinto C, Gunduz ME, Cardenas-Rojas A, Pacheco-Barrios K, Yang Y, Gonzalez-Mego P, Estudillo-Guerra A, Candido-Santos L, Mesia-Toledo I, Rafferty H, Caumo W, Fregni F. Optimised transcranial direct current stimulation (tDCS) for fibromyalgia-targeting the endogenous pain control system: a randomised, double-blind, factorial clinical trial protocol. BMJ Open. 2019 Oct 30;9(10):e032710. doi: 10.1136/bmjopen-2019-032710.
PubMed 31672712

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimized tDCS for Fibromyalgia: Targeting the Endogenous Pain Control System
ClinicalTrials.gov ID: NCT03371225
Acronym / sponsor ID: 2017P002524
Conditions: Fibromyalgia
Study type: Interventional
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: Spaulding Rehabilitation HospitalUniversity, hospital or other
Study start: 1 May 2019 (actual)
Primary completion: 26 Sep 2024 (actual)
Study completion: 26 Oct 2025 (actual)
First posted: 13 Dec 2017 (actual)
Results: Posted 10 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Active tDCS and Active Exercise	Experimental	Device: Active tDCS, Procedure: Active ExerciseActive tDCS for 20 min Active exercise (60-70% max HR) for 30 min
Sham tDCS and Active Exercise	Active comparator	Procedure: Active Exercise, Device: Sham tDCSSham tDCS for 20 min Active exercise (60-70% max HR) for 30 min
Active tDCS and Sham Exercise	Active comparator	Device: Active tDCS, Procedure: Sham ExerciseActive tDCS for 20 min Sham exercise (within 10% baseline HR) for 30 min
Sham TDCS and Sham Exercise	Sham comparator	Device: Sham tDCS, Procedure: Sham ExerciseSham tDCS for 20 min Sham exercise (within 10% baseline HR) for 30 min

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age range 18-65 years,
Diagnosis of FM pain according to the ACR 2010 criteria (existing pain for more than 6 months with an average of at least 4 on a 0-10 VAS scale) without other comorbid chronic pain diagnosis,
Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine,
Must have the ability to feel sensation by Von-Frey fiber on the forearm,
Able to provide informed consent to participate in the study.

Key exclusion criteria (8 listed)

Clinically significant or unstable medical or psychiatric disorder,
history of substance abuse within the past 6 months as self-reported (if subject reports a history of substance abuse, we will confirm using DSM V criteria),
Previous significant neurological history (e.g., traumatic brain injury), resulting in neurological deficits, such as cognitive or motor deficits, as self-reported,
Previous neurosurgical procedure with craniotomy,
Severe depression (If a patient scores >30 on the Beck Depression Inventory, one will obtain clearance. If one does not pass the medical clearance, one will not be included in the study)

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
Active tDCSAlso: tDCSActive tDCS: A 1x1 Low-intensity DC Stimulator will be used to deliver direct current through rubber electrodes in saline soaked sponges. The anode will be placed over the left primary motor cortex (M1) while the cathode will be placed over the contralateral supra-orbital area. 20 minutes of tDCS will be applied.	Device	Active tDCS and Active Exercise, Active tDCS and Sham Exercise
Active ExerciseAlso: Aerobic ExercisesParticipants will walk briskly in a treadmill (as to keep at 60-70% maximum heart rate) for 30 minutes	Procedure or surgery	Active tDCS and Active Exercise, Sham tDCS and Active Exercise
Sham tDCSAlso: Placebo tDCSActive tDCS: A 1x1 Low-intensity DC Stimulator will be used to deliver direct current through rubber electrodes in saline soaked sponges. The anode will be placed over the left primary motor cortex (M1) while the cathode will be placed over the contralateral supra-orbital area. Only 30 seconds of current will be applied for the sham condition.	Device	Sham TDCS and Sham Exercise, Sham tDCS and Active Exercise
Sham ExerciseAlso: Placebo Aerobic ExerciseParticipants will walk in a treadmill (as to keep at 10% within their baseline heart rate) for 30 minutes.	Procedure or surgery	Active tDCS and Sham Exercise, Sham TDCS and Sham Exercise

Primary outcome

Conditioning Pain Modulation (CPM)
Time frame: 6 weeks
Pain intensity was measured using the Numeric Pain Scale (NPS; 0 = no pain, 10 = worst pain). Higher scores indicate worse pain. A "pain-6 temperature" was first identified (temperature that elicits NPS = 6). Test stimulus: Pain-6 temperature applied for 30s; participants rated pain at 10, 20, and 30s. The test-stimulus score is the average of the three NPS ratings. Conditioned stimulus: After 5 minutes, the left hand was immersed in 10-12°C water for 30s while the same pain-6 temperature was applied again. Pain was rated the same way, and the conditioned-stimulus score is the average of the three NPS ratings. CPM calculation = (test-stimulus average) - (conditioned-stimulus average). Positive values = better endogenous pain inhibition; negative values = worse.
Temporal Slow Pain Summation (TSPS)
Time frame: 6 weeks
Participants first determined the temperature that elicited Numeric Pain Scale (NPS) = 6 ("pain-6"). Using this temperature, a train of 15 heat pulses (0.4 Hz) was delivered to the right forearm with a TSA-II thermode. Pain was rated using the NPS after the 1st and 15th heat stimulus. TSPS calculation: TSPS = NPS rating after the 15th stimulus - NPS rating after the 1st stimulus. Higher TSPS values represent greater temporal pain summation (worse outcome).

Results and safety

Results posted to the registry on 10 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active tDCS and Active Exercise	28	19
Sham tDCS and Active Exercise	28	20
Active tDCS and Sham Exercise	30	20
Sham TDCS and Sham Exercise	30	24

Primary outcome: Conditioning Pain Modulation (CPM)

Time frame: 6 weeks. Mean (95% Confidence Interval). Unit: Unit on a scale (NPS 0-10)

Measure	Active tDCS and Active Exercise n = 28	Sham tDCS and Active Exercise n = 28	Active tDCS and Sham Exercise n = 30	Sham TDCS and Sham Exercise n = 30
Value	0.36 (-0.23 to 0.95)	0.05 (-0.63 to 0.73)	0.21 (-0.40 to 0.83)	-0.55 (-1.01 to -0.09)

Primary outcome: Temporal Slow Pain Summation (TSPS)

Time frame: 6 weeks. Mean (95% Confidence Interval). Unit: Unit on a scale (NPS 0-10)

Measure	Active tDCS and Active Exercise n = 28	Sham tDCS and Active Exercise n = 28	Active tDCS and Sham Exercise n = 30	Sham TDCS and Sham Exercise n = 30
Value	-0.11 (-0.60 to 0.38)	0.48 (-0.29 to 1.25)	0.47 (-0.27 to 1.20)	0.09 (-0.44 to 0.61)

Adverse events

Time frame: 4.5 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active tDCS and Active Exercise	0 of 28 (0%)	23 of 28 (82.1%)	0 of 28
Sham tDCS and Active Exercise	0 of 28 (0%)	21 of 28 (75%)	0 of 28
Active tDCS and Sham Exercise	0 of 30 (0%)	18 of 30 (60%)	0 of 30
Sham TDCS and Sham Exercise	1 of 30 (3.3%)	28 of 30 (93.3%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38652585Pacheco-Barrios K, Teixeira PEP, Martinez-Magallanes D, Neto MS, Pichardo EA, Camargo L, Lima D, Cardenas-Rojas A, Fregni F. Brain compensatory mechanisms in depression and memory complaints in fibromyalgia: the role of theta oscillatory activity. Pain Med. 2024 Aug 1;25(8):514-522. doi: 10.1093/pm/pnae030.
Derived from this study: PubMed 31672712Castelo-Branco L, Uygur Kucukseymen E, Duarte D, El-Hagrassy MM, Bonin Pinto C, Gunduz ME, Cardenas-Rojas A, Pacheco-Barrios K, Yang Y, Gonzalez-Mego P, Estudillo-Guerra A, Candido-Santos L, Mesia-Toledo I, Rafferty H, Caumo W, Fregni F. Optimised transcranial direct current stimulation (tDCS) for fibromyalgia-targeting the endogenous pain control system: a randomised, double-blind, factorial clinical trial protocol. BMJ Open. 2019 Oct 30;9(10):e032710. doi: 10.1136/bmjopen-2019-032710.
Individual participant dataSharing planned: Yes. Upon completion of the trial and after publication of the primary manuscript, we plan to publish the de-identified dataset following the guidelines of our institution (Spaulding Rehabilitation Hospital/Partners Healthcare and Harvard Medical School).

Related trials for Fibromyalgia

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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.

Felipe Fregni, MD PhD MPH principal investigator

Spaulding Rehabilitation Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Active tDCS and Active Exercise in people with Fibromyalgia, run by Spaulding Rehabilitation Hospital at 1 site in United States.

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 5 inclusion and 8 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 10 Dec 2025. 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 United States. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 10 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Conditioning Pain Modulation (CPM) (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 NCT03371225, which also lists 2 linked publications.

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 10 Dec 2025.