NCT06989749

Brief Summary

This double-blind randomized crossover study aims to examine the effects of left primary motor cortex (M1) tDCS on evoked thermal pain perception, pain-related decision making, and placebo effects by manipulated pain and monetary offers accepted by others. The investigators plan to collect data for up to 50 participants who undergo four separate sessions: an initial pain calibration session and three experimental sessions with either anodal, cathodal, or sham tDCS. Each session includes pain testing before and after a single tDCS protocol (either anodal, cathodal, or sham), a pain-monetary decision-making task, and social placebo pain tests. All tasks following tDCS will take place inside the MR scanner. The investigators hypothesize that anodal M1 tDCS will decrease pain ratings, and that cathodal tDCS will increase them, both relative to the sham condition. The investigators will also examine the effects of M1 tDCS on social decision-making to examine whether it affects participants' valuation of pain and their altruistic behavior, as well as how these same factors impact pain sensation in the placebo task. The investigators hypothesize that participants will behave hyperaltruistically during the decision-making task, and that the same factors that influence choice will also impact pain perception in the same context.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Sep 2023Sep 2026

Study Start

First participant enrolled

September 9, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

3 years

First QC Date

May 8, 2025

Last Update Submit

May 22, 2025

Conditions

Keywords

transcranial direct current stimulationexperimental painpain-related decision-makingsocial placebo effects

Outcome Measures

Primary Outcomes (1)

  • Pain Visual Analogue Scale

    Self-reported pain level following each thermal stimulus, measured on a visual analog scale. 0-100 scale with 0 indicating no pain and higher values indicating more pain.

    3-10 sec post-stimulus throughout testing sessions, on average complete within 1 month

Study Arms (1)

Within-person Crossover

OTHER

This within-person crossover study involves a single arm, where each participant experiences an initial pain calibration session, followed by three full study sessions involving anodal, cathodal, or sham tDCS interventions. Only one intervention type (anodal, cathodal, or sham) is applied per session, in a randomized and double-blind fashion.

Other: Anodal tDCSOther: Cathodal tDCSOther: Sham tDCS

Interventions

Transcranial direct current stimulation (tDCS) is an experimental manipulation of brain circuitry using electrical current applied to the scalp. The equipment is commercially available (StarStim8, Neuroelectrics, Spain) and marketed for experimental research on brain function. Current is applied at 2 mA for 20 minutes. Electrodes are placed on the C3 and FP2 regions. There is a 30-second ramp-up and 30-second ramp-down of stimulation for each tDCS condition to minimize any discomfort during stimulation. In the anodal condition, real tDCS stimulation enters from the C3 electrode, and exits at the FP2 electrode.

Also known as: Anodal Transcranial Direct Current Stimulation
Within-person Crossover

Transcranial direct current stimulation (tDCS) is an experimental manipulation of brain circuitry using electrical current applied to the scalp. The equipment is commercially available (StarStim8, Neuroelectrics, Spain) and marketed for experimental research on brain function. Current is applied at 2 mA for 20 minutes. Electrodes are placed on the C3 and FP2 regions. There is a 30-second ramp-up and 30-second ramp-down of stimulation for each tDCS condition to minimize any discomfort during stimulation. In the cathodal condition, real tDCS stimulation enters from the FP2 electrode, and exits at the C3 electrode.

Also known as: Cathodal Transcranial Direct Current Stimulation
Within-person Crossover

This is the sham (or placebo) tDCS intervention. The tDCS device is applied for one minute, for a 30-second ramp-up and 30-second ramp-down of stimulation.

Also known as: Sham Transcranial Direct Current Stimulation
Within-person Crossover

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ages 18-55
  • Participants must be capable of performing experimental tasks (e.g., are able to read)
  • Fluent or native speakers of English

You may not qualify if:

  • No self-reported current or history of depression, bipolar disorder, or other psychiatric diagnosis.
  • No self-reported current seizure disorder (i.e., seizure within past 10 years)
  • No history of stroke or other major neurological diagnosis.
  • No self-reported current chronic pain, or acute pain within three months of the study period.
  • No current migraine disorder (i.e., 15 headache days or more in 1 month).
  • No use of central nervous system-effective medication or other medication for neurological/psychiatric treatment. No self-reported substance abuse within the last six months.
  • No contraindication to MRI or tDCS (e.g., pregnancy, claustrophobia, pacemakers, ear/cochlear implants, shrapnel injuries, clips, or other ferromagnetic/electrical objects/devices, diagnosed brain abnormality such as tumor, or skin lesions on the scalp.).
  • No contraindications for induced pain (e.g., no heart disease, high blood pressure, heart surgery, heart problems of any kind, severe asthma, respiratory problems of any kind, fibromyalgia, Raynaud's Syndrome or Disease, chronic pain, diabetes).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth College

Hanover, New Hampshire, 03755, United States

RECRUITING

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Central Study Contacts

Tor Wager D Principal Investigator, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Participants were blind to the tDCS type applied in each session. Personnel interacting directly with the study subjects are blind to the tDCS type in each session (Commonly known as "double blind"). Personnel analyzing data collected from the study are blind to the tDCS type applied in each session. Participants are blind to the exact temperatures (in Celsius) used in the study. Participants are blind to the temperatures received at the end of the decision making task.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Diana L. Taylor Distinguished Professor

Study Record Dates

First Submitted

May 8, 2025

First Posted

May 25, 2025

Study Start

September 9, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Electronic data will be stored indefinitely and will not be shared with other investigators without explicit permission from the overseeing IRB.

Locations