A study evaluating the effect of brain stimulation treatment on improving memory and thinking in individuals with moderate to severe head injuries, compared to a similar group not receiving the treatment

A DOUBLE-BLIND RANDOMIZED SHAM-CONTROLLED STUDY TO ASSESS THE EFFICACY AND TOLERABILITY OF HIGH DEFINITION TRANSCRANIAL DIRECT CURRENT STIMULATION (HD-tDCS) ON COGNITIVE FUNCTIONING IN MODERATE TO SEVERE TRAUMATIC BRAIN INJURY (TBI) - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/089128

Enrollment

Registered

2025-06-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: S063- Focal traumatic brain injury Health Condition 2: S062- Diffuse traumatic brain injury Health Condition 3: S061- Traumatic cerebral edema Health Condition 4: S064- Epidural hemorrhage Health Condition 5: S065- Traumatic subdural hemorrhage Health Condition 6: S066- Traumatic subarachnoid hemorrhage Health Condition 7: S068- Other specified intracranial injuries Health Condition 8: S069- Unspecified intracranial injury

Interventions

Intervention1: HIGH DEFINITION TRANSCRANIAL DIRECT CURRENT STIMULATION (HD-tDCS): 20 SESSIONS OF HD-tDCS ( 2 SESSIONS PER DAY WITH INTERVAL OF 3 HOURS BETWEEN EACH SESSION PER DAY) Control Interventio

Eligibility

Inclusion criteria

Inclusion criteria: 1.18-45 years of age 2.Any gender 3.Right handed individual 4.Participants who can read Hindi OR English language 5.History of Head injury (TBI) 6.Time Since Injury should be more than 6 months since TBI (chronic TBI) 7.History of Moderate to Severe TBI (Mayo TBI severity classification system) 8.Presence of at least one cognitive symptom on the Neurobehavioral Symptom Inventory (NS I)

Exclusion criteria

Exclusion criteria: 1.Individuals with Compound skull fracture 2.History of neurological or psychiatric illness prior to TBI in individuals. 3.Substance dependence with in previous 6 months (except Nicotine and Caffeine) 4.Presence of implanted electrical devices or any skull discontinuity over targeted brain regions 5.Post traumatic aphasia or psychosis or hydrocephalus or vision loss or upper limb weakness 6.Individuals who are currently pregnant or lactating 7.Presence of uncontrolled medical illness 8.History of receiving any neuromodulation therapy (CES, ECT, rTMS, tDCS) in previous 6 months 9.Currently undergoing Cognitive Rehabilitation Training 10.Recent changes in psychotropic medications (within previous 2 months) 11.Deny written informed consent (patient and LAR or NR) OR Uncooperative

Design outcomes

Primary

Measure	Time frame
Change in cognitive functioning in moderate to severe TBI and to assess any adverse effcct due to tDCS intervention in moderate-severe TBI (within both active and sham group)Timepoint: At baseline and after 10 sessions and after 20 sessions	—

Secondary

Measure	Time frame
Changes in qEEG (spectral power density for slow frequencies) and fNlRS (OxyHb changes) after tDCS in moderate to severe TBI (within both active and sham groups)Timepoint: At baseline and after 10 sessions and after 20 sessions	—

Countries

India

Contacts

Public ContactROHIT VERMA

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI

rohit.aiims@gmail.com9868005491

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026